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Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00983528
Recruitment Status : Unknown
Verified May 2011 by University of California, San Diego.
Recruitment status was:  Active, not recruiting
First Posted : September 24, 2009
Last Update Posted : May 4, 2011
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
University of California, San Diego

Brief Summary:
Clofarabine is approved by the FDA for the treatment of pediatric patients (1 to 21 years of age) with relapsed or refractory ALL. Alemtuzumab is approved by the FDA for treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients over the age of 18. These drugs have been used to treat patients with leukemia in other research studies like this one. Both drugs have individually been administered to adult patients with ALL with acceptable toxicity profiles. This study will evaluate the combination of clofarabine and alemtuzumab when administered to adult patients with relapsed or refractory ALL. Primary objectives of the study is to determine the maximum tolerated dose of clofarabine when administered with alemtuzumab, evaluate the safety of the combination, and assess for activity of the combination by evaluating response rate, effect on ALL progenitor cell population, and patients who are able to bridge to transplant.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Biological: Alemtuzumab Drug: Clofarabine Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia
Study Start Date : September 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011



Intervention Details:
  • Biological: Alemtuzumab
    3mg day 1,10mg day 2, 30mg day 3, 30mg day 5, 30mg day 8, then three times per calendar week thereafter for a total 12- 30mg doses
    Other Name: Campath
  • Drug: Clofarabine

    Dose Escalation

    Cycle 1 (30 days or until alemtuzumab completed) Clofarabine 10,20,30 or 40 mg/m2 days 5-9

    Cycle 2 and subsequent cycles (administered no more frequently than every 28 days) 10,20,30 or 40 mg/m2 days 1-5

    Other Name: Clolar


Primary Outcome Measures :
  1. To determine the maximum tolerated dose of clofarabine when administered in combination with alemtuzumab as measured by CTC version 3.0. (Phase 1) [ Time Frame: 2 years ]
  2. To determine the complete response rate based on bone marrow morphologic assessment. (Phase 2) [ Time Frame: 2 years ]
  3. To evaluate the safety and tolerability of clofarabine when administered in combination with alemtuzumab to patients with relapsed and refractory ALL as measured by CTC version 3.0 (Phase 2) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Evaluate how many patients who are potential allogeneic stem cell transplant candidates receive stem cell transplant. [ Time Frame: 2 years ]
  2. Determine progression-free survival and overall survival. [ Time Frame: 2 years ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide signed written informed consent. If a patient is under the 18 years of age the parent or the guardian will also need to provide written informed consent.
  2. Diagnosis of ALL (B or T lineage) who have received therapy with at least 1 but not more than 3 prior different induction regimens and have been deemed to have relapse or refractory disease. The phase II component of the study enrollment will be limited to 2 different prior induction regimens if patients are older than 30 years.
  3. ALL lymphoblasts with CD52 expression on at least 10% on lymphoblasts.
  4. Age >= 16 years of age.
  5. ECOG PS 0-2.
  6. Have adequate renal and hepatic functions.
  7. Subject or their patient or guardian is capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
  8. Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
  9. Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Subjects 16 and 17 years old must also adhere to effective contraception methods or abstinence during the study and for a minimum of 6 months after study and the nature of contraception or abstinence must be documented.
  10. CMV PCR negative prior to enrollment

Exclusion Criteria:

  1. Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
  2. Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea, CNS treatment or prophylaxis, or tyrosine kinase inhibitors for individuals with Philadelphia chromosome positive ALL. The patient must have recovered from all acute toxicities from any previous therapy.
  3. Lack of bone marrow or blood involvement by leukemia such as a documented CNS or testicular only relapse.
  4. Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
  5. Patients with any known or suspected Hepatitis B, C and HIV infections.
  6. Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  7. Pregnant or lactating patients.
  8. Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983528


Locations
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093
UCSD Medical Center
San Diego, California, United States, 92103
Rady Children's Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
University of California, San Diego
Genzyme, a Sanofi Company

Responsible Party: Danelle James, M.D., Rebecca and John Moores UCSD Cancer Center
ClinicalTrials.gov Identifier: NCT00983528     History of Changes
Other Study ID Numbers: 090331
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: May 2011

Keywords provided by University of California, San Diego:
cancer
lymphoblastic
leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Alemtuzumab
Clofarabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action