A Phase 1 interventional study of Allogeneic Bone Marrow Transplantation and Allogeneic Hematopoietic Stem Cell Transplantation in Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission and Allogeneic Hematopoietic Stem Cell Transplantation Recipient, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2022-01-06.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
This phase I trial studies the side effects and best dose of vorinostat when given together with fludarabine phosphate, clofarabine, and busulfan in treating patients with acute leukemia that is under control (remission) or has returned (relapse) undergoing donor stem cell transplant. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate, clofarabine, and busulfan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vorinostat together with fludarabine phosphate, clofarabine, and busulfan before a donor stem cell transplant may be a better treatment for patients with acute leukemia.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of SAHA (vorinostat) in combination with the preparative regimen fludarabine (fludarabine phosphate), clofarabine, and busulfan followed by allogeneic hematopoietic stem cell transplantation (SCT) for patients with advanced acute leukemia.
SECONDARY OBJECTIVES:
I. To determine the rate of graft versus host disease (GVHD), engraftment, progression-free survival (PFS) and overall survival (OS) for this treatment regimen.
OUTLINE: This is a dose-escalation study of vorinostat.
CONDITIONING REGIMEN: Patients receive vorinostat orally (PO) once daily (QD), fludarabine phosphate intravenously (IV) over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -6 to -3. Patients receiving a transplant from a human leukocyte antigen (HLA)-matched unrelated donor, receive anti-thymocyte globulin IV over 4 hours on days -3 to -1.
TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell or bone marrow transplant on day 0.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 70 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Exclusion Criteria:
CONDITIONING REGIMEN: Patients receive vorinostat PO QD, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -6 to -3. Patients receiving a transplant from a HLA-matched unrelated donor, receive anti-thymocyte globulin IV over 4 hours on days -3 to -1. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell or bone marrow transplant on day 0.
Procedure: Allogeneic Bone Marrow Transplantation · Procedure: Allogeneic Hematopoietic Stem Cell Transplantation · Biological: Anti-Thymocyte Globulin · Drug: Busulfan · Drug: Clofarabine · Drug: Fludarabine Phosphate · Procedure: Peripheral Blood Stem Cell Transplantation · Other: Pharmacological Study · Drug: Vorinostat
Undergo allogeneic peripheral blood stem cell or bone marrow transplant
Also known as: Allo BMT, Allogeneic BMT
Undergo allogeneic peripheral blood stem cell or bone marrow transplant
Also known as: Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT
Given IV
Also known as: Antithymocyte Globulin, Antithymocyte Serum, ATG, ATGAM, ATS, Thymoglobulin
Given IV
Also known as: 1, 4-Bis[methanesulfonoxy]butane, BUS, Bussulfam, Busulfanum, Busulfex, Busulphan, CB 2041, CB-2041, Glyzophrol, GT 41, GT-41, Joacamine, Methanesulfonic Acid Tetramethylene Ester, Methanesulfonic acid, tetramethylene ester, Mielucin, Misulban, Misulfan, Mitosan, Myeleukon, Myeloleukon, Myelosan, Mylecytan, Myleran, Sulfabutin, Tetramethylene Bis(methanesulfonate), Tetramethylene bis[methanesulfonate], WR-19508
Given IV
Also known as: Clofarex, Clolar
Given IV
Also known as: 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara, SH T 586
Undergo allogeneic peripheral blood stem cell or bone marrow transplant
Also known as: PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation
Correlative studies
Given PO
Also known as: L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
Maximum tolerated dose of vorinostat when given in combination with fludarabine phosphate, clofarabine, and busulfan before stem cell transplant assessed using Common Terminology Criteria for Adverse Events version 4
The 2-stage time-to-event continual reassessment method will be used. Toxicity will be tabulated by dose, type, and grade. The probability of toxicity over 30 days as a function of dose will be estimated by fitting a Bayesian binary outcome regression model.
Time frame: 30 days
Recurrence-free survival
Will be estimated by the Kaplan and Meier method.
Time frame: Up to 5 years
Overall survival
Will be estimated by the Kaplan and Meier method.
Time frame: Up to 5 years
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center