NCT02083250

Fludarabine Phosphate, Clofarabine, and Busulfan With Vorinostat in Treating Patients With Acute Leukemia in Remission or Relapse Undergoing Donor Stem Cell Transplant

Fludarabine/Clofarabine/Busulfan Combined With SAHA in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Lymphoblastic Leukemia in Remission
• Acute Myeloid Leukemia in Remission
• Allogeneic Hematopoietic Stem Cell Transplantation Recipient
• Myelodysplastic Syndrome
• Previously Treated Myelodysplastic Syndrome
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Acute Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	Allogeneic Bone Marrow Transplantation	Undergo allogeneic peripheral blood stem cell or bone marrow transplant
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation	Undergo allogeneic peripheral blood stem cell or bone marrow transplant
BIOLOGICAL	Anti-Thymocyte Globulin	Given IV
DRUG	Busulfan	Given IV
DRUG	Clofarabine	Given IV
DRUG	Fludarabine Phosphate	Given IV
PROCEDURE	Peripheral Blood Stem Cell Transplantation	Undergo allogeneic peripheral blood stem cell or bone marrow transplant
OTHER	Pharmacological Study	Correlative studies
DRUG	Vorinostat	Given PO

Timeline

• Start date: 2014-03-06
• Primary completion: 2021-11-12
• Completion: 2021-11-12
• First posted: 2014-03-11
• Last updated: 2022-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study