Clinical Research Protocols
For Acute Myelogenous Leukemia
and Myelodysplastic Syndrome
Compiled by Margaret Gross-King, RN, MS, OCN
Clinical Research Manager,
H. Lee Moffitt Cancer Center & Research Institute
This list of clinical research protocols relating to acute myelogenous
leukemia and myelodysplastic syndrome is compiled for your convenience.
URCC-G2495, NCI-T95-0036O, URCC-U6495M Phase II Study of Sequential TOPO and
TOPO/VP-16 for Refractory or Relapsed Acute Myelogenous Leukemia (summary last modified
01/97).
Chairperson: Alex Yuang-Chi Chang. Lead organization: University of Rochester Cancer
Center. Age range: 15 and over.
MDA-DM-95131, NCI-T95-0061D Phase I Study of 9-AC as a 7-Day Continuous Infusion in
Refractory Acute Leukemia and Blastic Phase Chronic Myelogenous Leukemia (summary last
modified 01/97).
Chairperson: Hagop M. Kantarjian. Lead organization: University of Texas - M.D.
Anderson Cancer Center. Age range: over 15.
MDA-DM-94109, NCI-T94-0157D Phase I Study of Pyrazine Diazohydroxide Administered
on a 5-Day Bolus Schedule for Refractory Acute Leukemias and Blastic Phase Chronic
Myelogenous Leukemia (summary last modified 05/96).
Chairperson: Susan Mary O’Brien. Lead organization: University of Texas - M.D.
Anderson Cancer Center. Age range: over 15.
MDA-DM-94095, NCI-T94-0148C Phase I/II Randomized Study of TOPO/ARA-C vs TOPO/VP-16
vs VP-16/TOPO for Refractory Acute Myelogenous Leukemia (summary last modified 10/96).
Chairperson: Hagop M. Kantarjian. University of Texas - M.D. Anderson Cancer Center.
Age range: over 15.
JHOC-9446, NCI-T94-0196D Phase I Study of Phenylbutyrate for Myelodysplastic
Syndrome and Relapsed Acute Myeloid Leukemia (summary last modified 03/97).
Chairperson: Steven D. Gore. Lead organization: Johns Hopkins Oncology Center. Age
range: over 18.
MSKCC-94088A3, NCI-H94-0571 Phase II Study of MOAB HuM195 as Early Post-Remission
Therapy Followed by Cytarabine/Idarubicin and Maintenance With HuM195 for Acute
Promyelocytic Leukemia in Clinical Complete Remission (summary last modified 01/97).
Chairperson: David A. Scheinberg. Lead organization: Memorial Sloan- Kettering Cancer
Center. Age range: 12 and over.
MCV-MCC-9409-2CC, NCI-V96- 0966 Phase I Study of Deoxycytidine Chemoprotection With
High- Dose Cytarabine in Refractory Acute Myelogenous Leukemia and Other Hematologic
Malignancies (summary last modified 10/96).
Chairperson: Steven Grant. Lead organization: Massey Cancer Center, Medical College of
Virginia. Age range: 18 and over.
SWOG-S9617, SWOG-9617 Phase I Study of Mitoxantrone/Etoposide/PSC 833 in Patients
56 Years of Age and Over With Previously Untreated Acute Myeloid Leukemia (summary last
modified 02/97).
Chairperson: Thomas R. Chauncey. Lead organization: Southwest Oncology Group. Age
range: 56 and over.
MSKCC-96014A1, NCI-H96-1101 Phase I Study of Bismuth-213- Labeled Humanized
Monoclonal Antibody HuM195 in Advanced Myeloid Malignancies (summary last modified 01/97).
Chairperson: Joseph G. Jurcic. Lead organization: Memorial Sloan-Kettering Cancer
Center. Age range: no age specified.
CWRU-ICC-2994, NCI-T94-0078D Phase I Study of Sequential Topotecan and VP-16 for
Relapsed/Refractory Acute Myelogenous and Lymphocytic Leukemias and for Blastic Phase
Chronic Myelogenous Leukemia (summary last modified 08/96).
Chairperson: Brenda W. Cooper. Lead organization: Case Western Reserve
University/Ireland Cancer Center. Age range: over 18.
FHCRC-1008.00, NCI-H96-0922 Phase I Pilot Study of High-Dose Chemotherapy and
Interleukin-2- Incubated Peripheral Blood Stem Cells Followed by Additional Interleukin-2
Therapy for Acute Myelogenous Leukemia (summary last modified 06/97).
Chairperson: Leona Holmberg. Lead organization: Fred Hutchinson Cancer Research Center.
Age range: 60 and under.
MSKCC-93161, NCI-H94-0460 Phase II Study of PBSC Rescue Following Myeloablative
TBI/VP-16 for Acute Leukemia (summary last modified 12/94).
Chairperson: Peter Maslak. Lead organization: Memorial Sloan-Kettering Cancer Center.
Age range: 16 to 65.
MSKCC-96044, NCI-V96-0941 Phase II Study of High-Dose Cytarabine With a Single High
Dose of Idarubicin for Newly Diagnosed Acute Myelogenous Leukemia: the AML-3 Protocol
(summary last modified 07/97).
Chairperson: Peter Maslak. Lead organization: Memorial Sloan-Kettering Cancer Center.
Age range: 18 and over.
CLB-9620 Phase II Study of Autologous Stem Cell Transplantation Following
ARA-C/VP-16 and BU/VP-16 for Acute Myeloid Leukemia in Second Remission (summary last
modified 12/96).
Chairperson: Charles A. Linker. Lead organization: Cancer and Leukemia Group B. Age
range: 15 to 59.
MSKCC-92103A2, NCI-H92-0143 Phase II Study of BU/CTX Cytoreduction of Acute and
Chronic Leukemias and Myelodysplastic Syndromes in Patients Undergoing Allogeneic Bone
Marrow Transplantation (summary last modified 05/96).
Chairperson: Esperanza B. Papadopoulos. Lead organization: Memorial Sloan-Kettering
Cancer Center. Age range: under 50 or special approval.
MSKCC-93045, NCI-H93-0293 Phase III Randomized Study of Unmodified vs
T-Cell-Depleted, Allogeneic, HLA-Identical Bone Marrow Transplantation in Patients With
Acute Leukemia in First or Second Remission (summary last modified 06/95).
Chairperson: Farid Boulad. Lead organization: Memorial Sloan-Kettering Cancer Center.
Age range: 5 to 55 preferred.
FHCRC-600.02, NCI-H95-0674 Phase I/II Pilot Study of G-CSF-Stimulated Donor
Peripheral Blood Mononuclear Cells for Post-Transplant Relapse of Hematologic Malignancies
(summary last modified 02/97).
Chairperson: Mary Flowers. Lead organization: Fred Hutchinson Cancer Research Center.
Age range: any age.
FHCRC-964.00, NCI-V96-0921 Phase II Trial of Induction and Consolidation With
Idarubicin and Cytarabine With G-CSF Followed by Myeloablative Chemoradiotherapy and
Autologous Peripheral Blood Stem Cell Transplantation for Myelodysplasia and Secondary
Acute Myeloid Leukemia (summary last modified 03/97).
Chairperson: Jeanne E. Anderson. Lead organization: Fred Hutchinson Cancer Research
Center. Age range: 65 and under.
RPCI-DS-96-48, NCI-G97-1152 Phase III Study of High Dose Cytarabine and Idarubicin
Induction, High-Dose Etoposide and Cyclophosphamide Intensification, Autologous Stem Cell
Transplantation and Interleukin-2 Immune Modulation in Previously Untreated De Novo and
Secondary Adult Acute Myeloid Leukemia (AML) (summary last modified 05/97).
Chairperson: Maria R. Baer. Lead organization: Roswell Park Cancer Institute. Age
range: over 25.
NCI-96-C-0064F, NCI-T95-0042N Phase I Study of the Immunotoxin LMB-2 in
Tac-Expressing Leukemias and Lymphomas (summary last modified 05/97).
Chairperson: Robert Kreitman. Lead organization: Laboratory of Molecular Biology. Age
range: 18 and over.
MDA-DM-94078, NCI-G96-1001 Phase II Study of Filgrastim-Stimulated HLA Identical
Allogeneic Peripheral Blood Stem Cells for Patients With High-Risk Acute Myelogenous
Leukemia or CML in Blast Crisis (summary last modified 06/97).
Chairperson: Sergio Giralt. Lead organization: University of Texas - M.D. Anderson
Cancer Center. Age range: 55 to 70.
CLB-9420 Phase I Study of Induction and Post-Remission Therapy With ADE
(Cytarabine/Daunorubicin/Etoposide) or ADEP (ADE Plus PSC 833) Followed by IL-2 for
Patients Age 60 and Over With Acute Myeloid Leukemia (summary last modified 07/97).
Chairperson: Edward James Lee. Lead organization: Cancer and Leukemia Group B. Age
range: 60 and over.
MSKCC-89119A5, NCI-H89-0254 Phase II Study of T-Cell Depleted Allogeneic Bone
Marrow Transplantation for Acute and Chronic Leukemias and Preleukemic/ Myelodysplastic
Syndromes (summary last modified 02/97).
Chairperson: James William Young. Lead organization: Memorial Sloan- Kettering Cancer
Center. Age range: under 55 or special approval.
SWOG-9126 Phase III Randomized Study of ARA-C/DNR With vs Without the Drug
Resistance Inhibitor CYSP in High-Risk Patients With AML (summary last modified 04/96).
Chairperson: Alan Francis List. Lead organization: Southwest Oncology Group. Age range:
18 to 70.
CLB-9621 Phase I Study of MDR Modulation With PSC-833 With a Pilot Study of
Cytogenetic Risk Adapted Consolidation Followed by a Phase II Pilot Study of Immunotherapy
With rIL-2 in Previously Untreated Patients With Acute Myelogenous Leukemia (AML) and Less
Than 60 Years Old (summary last modified 07/97).
Chairperson: Jonathan Eliahu Kolitz. Lead organization: Cancer and Leukemia Group B.
Age range: 15-60.
SWOG-9333 Phase III Randomized Study of ARA-C/DNR vs DHAD/ VP-16 Induction Therapy
Followed by ARA-C/DNR Consolidation Therapy in Older Patients With Previously Untreated
Acute Myeloid Leukemia (summary last modified 10/96).
Chairperson: Jeanne E. Anderson. Lead organization: Southwest Oncology Group. Age
range: 56 and over.
Myelodysplastic Syndrome
UW-26-245-B, NCI-V96-0848 Phase I Trial of Subcutaneous Outpatient Interleukin-2
for Patients With Myelodysplastic Syndrome (summary last modified 04/97).
Chairperson: Philip Gold. Lead organization: University of Washington Medical Center.
Age range: 15 and over.
IUMC-951023, NCI-T95-0088O Phase II Study of Interleukin-2 for Myelodysplastic
Syndromes (summary last modified 02/97).
Chairperson: Michael Steven Gordon. Lead organization: Indiana University Cancer
Center. Age range: 18 and over.
MDA-DM-95033, NCI-T95-0079D Phase II Study of TOPO/ARA-C in Myelodysplastic
Syndrome (summary last modified 08/96).
Chairperson: Miloslav Beran. Lead organization: M.D. Anderson Cancer Center. Age range:
over 15.
JHOC-9446, NCI-T94-0196D Phase I Study of Phenylbutyrate for Myelodysplastic
Syndrome and Relapsed Acute Myeloid Leukemia (summary last modified 03/97).
Chairperson: Steven D. Gore. Lead organization: Johns Hopkins Oncology Center. Age
range: over 18.
DFCI-96278, NCI-T96-0112 Phase II Study of All-Trans Retinoic Acid (Tretinoin) and
Bryostatin 1 in Patients With Refractory Acute Myeloid Leukemia or Myelodysplastic
Syndromes (summary last modified 07/97).
Chairperson: Richard Maury Stone. Lead organization: Dana-Farber Cancer Institute. Age
range: 18 and over.
SPARTA-RII-9601, NCI-V96-1069 Phase I/II Study of N-(4-Carboxyphenyl) Retinamide
for Refractory Anemia or Refractory Anemia With Ringed Sideroblasts (summary last modified
06/97).
Chairperson: Edgar M. Moran. Lead organization: Sparta Pharmaceuticals, Inc. Age range:
18 and over.
E-3996 Phase II Study of GM-CSF With Intermediate-Dose Cytarabine and Mitoxantrone
in High-Risk Myelodysplastic Syndrome (summary last modified 08/97).
Chairperson: John M. Bennett. Lead organization: Eastern Cooperative Oncology Group.
Age range: 18 and over.
WSU-D-696-87, NCI-V93-0345 Phase II Study of Allogeneic or Syngeneic Bone Marrow
Transplantation Following Cytoreduction With BU/CTX for Low-Risk and BU/ARA-C/CTX for
High-Risk Acute Nonlymphocytic Leukemia, Myelodysplastic Syndromes, and Secondary Acute
Myeloid Leukemia (summary last modified 06/95).
Chairperson: Chatchada Karanes. Lead organization: Barbara Ann Karmanos Cancer
Institute. Age range: 60 and under.
EORTC-06962 Phase III Randomized Study to Assess Intensification of the
Conditioning Regimen for Allogeneic Stem Cell Transplantation for Leukemia or
Myelodysplastic Syndrome With a High Risk of Relapse (summary last modified 08/97).
Chairperson: Theo De Witte. Lead organization: EORTC Leukemia Cooperative Group. Age
range: not specified.
EORTC-58921 Phase III Randomized Comparison of IDA vs DHAD Combined With
ARA-C/VP-16 for Induction and Combined With High-Dose ARA-C for Intensification in
Children With Newly Diagnosed AML or Myelodysplastic Syndrome (summary last modified
06/93).
Chairperson: Catherine Behar. Lead organization: EORTC Children’s Leukemia
Cooperative Group. Age range: under 15.
EORTC-06961 Phase III Randomized Comparison of Autologous Peripheral Blood Stem
Cell Transplantation vs Second Intensive Consolidation With High-Dose Cytarabine Following
Common Induction and Consolidation in Patients With Poor Prognosis Myelodysplastic
Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (sAML) to MDS of More Than 6
Months Duration (summary last modified 08/97).
Chairperson: Theo De Witte. Lead organization: EORTC Leukemia Cooperative Group. Age
range: 16 to 60.
CCG-2891 Phase III Randomized Study of Intensive Schedule vs Standard Schedule
Induction Chemotherapy With DNR/ARA-C/ VP-16/ TG/DM and of Autologous BMT vs Combination
Chemotherapy for Intensification in Children With ANLL or Myelodysplastic Syndrome
(summary last modified 09/95).
Chairperson: Franklin O. Smith. Lead organization: Children’s Cancer Group. Age
range: under 21.
CCG-2961 Phase III Randomized Study for Untreated Pediatric Acute Myelogenous
Leukemia and Myelodysplastic Syndromes: Intensively-Timed Induction Chemotherapy, Followed
by Consolidation With the Same Chemotherapy vs Fludarabine/Cytarabine/Idarubicin, Followed
by Intensification Either With High-Dose Cytarabine/As-paraginase With vs Without
Subsequent IL-2 or With AlBMT (summary last modified 08/97).
Chairperson: Beverly J. Lange. Lead organization: Children’s Cancer Group. Age
range: under 22.
Legend for abbreviations:
CCG = Children’s Cancer Study Group
CLB = Cancer & Leukemia Group B
CWRU = Case Western Reserve University
DFCI = Dana-Farber Cancer Institute
E = Eastern Cooperative Oncology Group
EORTC = European Organization for Research on Treatment of Cancer
FHCRC = Fred Hutchinson Cancer Research Center
IUMC = Indiana University Medical Center
JHOC = Johns Hopkins Oncology Center
MCV = Medical College of Virginia
MDA = M.D. Anderson Cancer Center
MSKCC = Memorial Sloan-Kettering Cancer Center
RPCI = Roswell Park Cancer Institute
SPARTA = Sparta Pharmaceuticals, Inc.
SWOG = Southwest Oncology Group
URCC = University of Rochester Cancer Center
UW = University of Washington
WSU = Wayne State University
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