NCT02083250

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

Completed Phase 1 Last updated 6 January 2022

What this trial tests

Phase 1 trial testing Allogeneic Bone Marrow Transplantation in Acute Lymphoblastic Leukemia in Remission in 70 participants. Completed in 12 November 2021.

Timeline

6 March 2014

Primary endpoint
12 November 2021

12 November 2021

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	6 March 2014
Primary completion	12 November 2021
Estimated completion	12 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Allogeneic Bone Marrow Transplantation
• Allogeneic Hematopoietic Stem Cell Transplantation
• Anti-Thymocyte Globulin
• Busulfan — full drug profile →
• Clofarabine (CLOFARABINE) — full drug profile →
• Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
• Peripheral Blood Stem Cell Transplantation
• Pharmacological Study
• Vorinostat

Conditions studied

• Acute Lymphoblastic Leukemia in Remission — all drugs for Acute Lymphoblastic Leukemia in Remission →
• Acute Myeloid Leukemia in Remission — all drugs for Acute Myeloid Leukemia in Remission →
• Allogeneic Hematopoietic Stem Cell Transplantation Recipient — all drugs for Allogeneic Hematopoietic Stem Cell Transplantation Recipient →
• Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Under 60, any sex, with Acute Lymphoblastic Leukemia in Remission or Acute Myeloid Leukemia in Remission. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metabolism, Biochemical Actions, and Chemical Synthesis of Anticancer Nucleosides, Nucleotides, and Base Analogs.
   Shelton J, Lu X, Hollenbaugh JA, Cho JH, et al · · 2016 · cited 219× · PMID 27960273 · DOI 10.1021/acs.chemrev.6b00209
2. Current Approaches in the Treatment of Relapsed and Refractory Acute Myeloid Leukemia.
   Ramos NR, Mo CC, Karp JE, Hourigan CS. · · 2015 · cited 91× · PMID 25932335 · DOI 10.3390/jcm4040665
3. Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
   Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
4. The epigenome in pediatric acute lymphoblastic leukemia: drug resistance and therapeutic opportunities.
   Meyer LK, Hermiston ML. · · 2019 · cited 6× · PMID 35582725 · DOI 10.20517/cdr.2019.11