Clinical trial · Interventional

Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation

Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Acute Lymphoblastic Leukemia or Lymphoma, or Biphenotypic Leukemia

NCT00990249CI-TRIAL-00034159completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The goal of this clinical research study is to test the safety of giving clofarabine in combination with busulfan, followed by an allogeneic (from a donor) stem cell transplant, in patients with advanced leukemia or lymphoma.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Acute Lymphoblastic Leukemia	Acute Lymphoblastic Leukemia	ONTOLOGY_EXACT	0.98
Allogeneic Haematopoietic Stem Cell Transplantation	—	UNRESOLVED	—
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Busulfan	Drug	Busulfan	ALIAS
Clofarabine	Drug	Clofarabine	ALIAS
Stem Cell Transplant	Procedure	—	UNRESOLVED
Thymoglobulin	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Busulfan + Clofarabine + Stem Cell Transplant
description
Busulfan test dose 32 mg/m\^2 by vein over 45 minutes on Day -8; following doses on Days -6 to -3 derived from pharmacokinetic (PK) testing done up to 11 times over 11 hours after test dose. Clofarabine 40 mg/m\^2 by vein over 1 hour daily Day -6 through Day -3. Thymoglobulin 0.5 mg/kg on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1; only patients with HLA nonidentical or unrelated donors. Stem cell infusion on Day 0.
interventionNames
1. Drug: Busulfan
2. Drug: Clofarabine
3. Drug: Thymoglobulin
4. Procedure: Stem Cell Transplant

Primary outcomes (1)

measure
Treatment-Related Mortality (TRM) Defined as Non Relapse Mortality (NRM)
timeFrame
100 Days
description
NRM was defined as death from any cause other than disease progression or relapse and reported as percentage of participant deaths. Treatment related deaths after transplant are defined either by deaths which could not be attributed to disease relapse or progression or by deaths without previous relapse or progression. For TRM at day 100, Bayesian method of Thall, Simon, and Estey used to perform interim monitoring.

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 65 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patients with biopsy-proven acute lymphoblastic leukemia, acute lymphoblastic lymphoma, or acute biphenotypic leukemia in remission or relapse.
2. Adequate renal function, as defined by estimated serum creatinine clearance \>60 ml/min.
3. Bilirubin equal or less than 1.5 (unless Gilbert's Syndrome), serum glutamate pyruvate transaminase (SGPT) \<3 X upper limit of normal and alkaline phosphatase \<2 X upper limit of normal.
4. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) at least 45% of expected corrected for hemoglobin. Children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air.
5. Adequate cardiac function with left ventricular ejection fraction at least 45% on appropriate medical therapy. No uncontrolled arrhythmias or symptomatic cardiac disease.
6. Zubrod performance status \<2 or Lansky/Karnofsky PS equal or greater to 70%.
7. Patients must have a related, genotypically HLA identical donor, or they must have a unrelated donor who is 8/8 HLA match by high resolution typing.
8. Patient or patient's legal representative, parent(s) or guardian should provide written informed consent. Assent of a minor if participant's age is at least seven and less than eighteen years.
9. Negative Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization.

Exclusion Criteria:

1. Patients with unresolved grade \>2 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.
2. Patients with active central nervous system (CNS) disease.
3. Evidence of acute or chronic active hepatitis or cirrhosis.
4. Uncontrolled infection, including HIV, HTLV-1, hepatitis B or hepatitis C viremia.
5. Patients greater than 65 years-old.
6. Prior autologous or allogeneic hematopoietic stem cell transplant.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Oct 1, 2009
Primary completion: May 1, 2016
Completion: May 1, 2016
First posted: Oct 6, 2009
Last update posted: Aug 7, 2018
Results first posted: Aug 7, 2018
Enrollment: 120 (actual)
Lead sponsor: M.D. Anderson Cancer Center OTHER
Keywords: Acute Lymphoblastic Leukemia, ALL, Acute lymphoblastic lymphoma, acute biphenotypic leukemia, Allogeneic hematopoietic cell transplantation, HCT, Stem Cell Transplant, Treatment-related mortality, Tyrosine kinase inhibitors, TKI, Busulfan, Busulfex, Myleran, Clofarabine, Clolar, Clofarex, Gleevec, Imatinib Mesylate

Data updated 22 days agoSource updated Aug 7, 2018source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.