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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02083250
Phase
PHASE1
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
N/A - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 6, 2014
Status verified
Dec 2021
Primary completion
Nov 12, 2021
Completion
Nov 12, 2021

Study Design

Enrollment
70 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (vorinostat, chemotherapy, SCT)
    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.

Primary Outcome Measure

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 [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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