CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 201 enrolled
Drug / intervention
Fludarabine monophosphate +5 moredrug
Likely dose
Fludarabine monophosphate 40 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01572662
NCT01572662Phase 2Completed
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Phase II Study of Timed Sequential Busulfan in Combination With Fludarabine in Allogeneic Stem Cell Transplantation

M.D. Anderson Cancer Center·interventional·Posted Apr 6, 2012·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating Fludarabine monophosphate, Busulfan, and 4 other interventions for Leukemia and 9 related conditions. Completed, enrolled 201 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if giving busulfan and fludarabine before a stem cell transplant can help control the disease better than the standard method in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses of busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of busulfan and fludarabine during the week before the stem cell transplant, rather than the standard method of giving 4 doses of busulfan and fludarabine only during the week before the stem cell transplant. The safety of this combination therapy will also be studied. Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants. Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer cells to die.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myeloproliferative Diseases, Non-Hodgkins Lymphoma, Hodgkins Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2012
Enrollment StartApr 11, 2012
Primary CompletionAug 11, 2022
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 14.2 years ago

Interventions

Fludarabine monophosphatedrug

40 mg/m2 by vein on Days -6 through -3.

Busulfandrug

First two doses of Busulfan, 80 mg/m2 administered as an outpatient or as an inpatient to facilitate for this pharmacokinetically directed therapy. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies.

Stem Cell Infusionprocedure

Fresh or cryopreserved bone marrow or peripheral blood progenitor cells infused on Day 0.

Tacrolimusdrug

Starting dose of 0.015 mg/kg (ideal body weight) as 24 hour continuous infusion daily adjusted to achieve therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after day +90 if no graft versus host disease (GVHD) present.

Methotrexatedrug

5 mg/m2 by vein on Days 1, 3, 6 and 11 post transplant.

G-CSFdrug

5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is \> 500 \* 10/L for 3 consecutive days.