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Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2009
First Received: December 14, 2006   Last Updated: September 14, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: Genzyme
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00412243
  Purpose

Primary Objectives (Phase I):

  1. To establish toxicities and safety of the proposed combination
  2. To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination to proceed with the phase II part of the study

Primary Objectives (Phase II):

  1. To establish the efficacy (complete and overall response) of the proposed combination.
  2. To analyze pharmacokinetic (PK) and pharmacodynamic (PD) properties of clofarabine as well as the impact on DNA repair of leukemic blasts with the proposed combination.

Condition Intervention Phase
Burkitt's Lymphoma
Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia
Drug: Clofarabine
Drug: Cyclophosphamide
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I/II Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: Continual reassessment method; 3-5 Day Cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: March 2006
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Clofarabine + Cyclophosphamide: Experimental Drug: Clofarabine
40 mg/m^2 Daily for 3 Days
Drug: Cyclophosphamide
Beginning dose 200 mg/m^2 every 12 hours for 3 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously treated ALL (including Burkitt's lymphoma and lymphoblastic lymphoma) in relapse or primary refractory. For patients in first relapse, the first remission duration may not exceed 12 months.
  2. Age >/= 21 years.
  3. Zubrod performance status </= 3.
  4. Adequate liver function (bilirubin </= 2.5 mg/dL and SGPT or SGOT </= 3 x ULN, unless considered due to tumor), and renal function (glomerular filtration rate [GFR] >/= 60 mL/min). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 5 mg/dL and creatinine </= 3 mg/dL.
  5. Male and female patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study enrollment (applies only if patient is of childbearing potential. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized).

Exclusion Criteria:

  1. Patients with active heart disease (NYHA class >/= 3 as assessed by history and physical examination).
  2. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 45% are excluded.
  3. Patients who receive other chemotherapy. Patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. (Concurrent therapy for CNS prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition following discussion with the Principal Investigator.
  4. Pregnant and breast-feeding patients are excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412243

Contacts
Contact: Stefan Faderl, MD 713-745-4613

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Stefan Faderl, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genzyme
Investigators
Principal Investigator: Stefan Faderl, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( Stefan Faderl, MD / Associate Professor )
Study ID Numbers: 2005-0552
Study First Received: December 14, 2006
Last Updated: September 14, 2009
ClinicalTrials.gov Identifier: NCT00412243     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Burkitt's Lymphoma
Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia
Clofarabine
Clofarex
Clolar
Cyclophosphamide
Neosar
Cytoxan

Additional relevant MeSH terms:
Leukemia, Lymphoid
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Tumor Virus Infections
Cyclophosphamide
Neoplasms, Experimental
Lymphoma, B-Cell
Leukemia
Therapeutic Uses
Epstein-Barr Virus Infections
Alkylating Agents
Lymphoma
Clofarabine
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
Lymphatic Diseases
Neoplasms
Burkitt Lymphoma
Myeloablative Agonists
DNA Virus Infections
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 08, 2010