Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00990249
First received: October 2, 2009
Last updated: May 10, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Allogeneic Haematopoietic Stem Cell Transplantation Acute Lymphoblastic Leukemia |
Drug: Busulfan Drug: Clofarabine Drug: Thymoglobulin Procedure: Stem Cell Transplant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Acute Lymphoblastic Leukemia or Lymphoma, or Biphenotypic Leukemia |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Acute Leukemia of Ambiguous Lineage
Lymphosarcoma
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Treatment-Related Mortality (TRM) [ Time Frame: Baseline and at day 100 of treatment ] [ Designated as safety issue: Yes ]For TRM at day 100, Bayesian method of Thall, Simon, and Estey used to perform interim monitoring. Rates of 100-day progression-free survival (PFS) and TRM estimated separately by cohort and provided with 95% credible intervals.
| Enrollment: | 120 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2016 |
| Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Busulfan + Clofarabine + Stem Cell Transplant
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. |
Drug: 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.
Other Names:
Drug: Clofarabine
40 mg/m^2 by vein over 1 hour daily Day -6 through Day -3
Other Names:
Drug: 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
Other Names:
Procedure: Stem Cell Transplant
Stem cell infusion on Day 0.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 65 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with biopsy-proven acute lymphoblastic leukemia, acute lymphoblastic lymphoma, or acute biphenotypic leukemia in remission or relapse.
- Adequate renal function, as defined by estimated serum creatinine clearance >60 ml/min.
- 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.
- 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.
- Adequate cardiac function with left ventricular ejection fraction at least 45% on appropriate medical therapy. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status <2 or Lansky/Karnofsky PS equal or greater to 70%.
- 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.
- 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.
- 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:
- 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.
- Patients with active central nervous system (CNS) disease.
- Evidence of acute or chronic active hepatitis or cirrhosis.
- Uncontrolled infection, including HIV, HTLV-1, hepatitis B or hepatitis C viremia.
- Patients greater than 65 years-old.
- Prior autologous or allogeneic hematopoietic stem cell transplant.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990249
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990249
Locations
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Partow Kebriaei, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00990249 History of Changes |
| Other Study ID Numbers: | 2009-0209 NCI-2012-01270 |
| Study First Received: | October 2, 2009 |
| Last Updated: | May 10, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Busulfan Antilymphocyte Serum |
Clofarabine Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Alkylating Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on September 30, 2016