Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
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: April 10, 2013
Last verified: April 2013
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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:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Treatment-Related Mortality [ Time Frame: Baseline and at day 100 of treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2014 (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 |
| 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), SGPT <3 X upper limit of normal and alkaline phosphatase <2 X upper limit of normal.
- Adequate pulmonary function with FEV1, FVC and 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 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990249
Contacts
| Contact: Partow Kebriaei, MD | 713-745-0663 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Partow Kebriaei, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Partow Kebriaei, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00990249 History of Changes |
| Other Study ID Numbers: | 2009-0209 |
| Study First Received: | October 2, 2009 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
acute biphenotypic leukemia Acute Lymphoblastic Leukemia ALL Acute lymphoblastic lymphoma 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:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antilymphocyte Serum Busulfan |
Clofarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 16, 2013