Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia
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ClinicalTrials.gov Identifier: NCT00983528 |
Recruitment Status :
Terminated
(Support withdrawn due to slow accrual)
First Posted : September 24, 2009
Results First Posted : August 12, 2020
Last Update Posted : August 12, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoblastic Leukemia | Biological: Alemtuzumab Drug: Clofarabine | Phase 1 Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
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 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

- 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 dosesOther 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
- 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 ]
- Number of Adverse Events [ 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 |
Inclusion Criteria:
- 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.
- 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.
- ALL lymphoblasts with CD52 expression on at least 10% on lymphoblasts.
- Age >= 16 years of age.
- ECOG PS 0-2.
- Have adequate renal and hepatic functions.
- 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.
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
- 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.
- CMV PCR negative prior to enrollment
Exclusion Criteria:
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
- 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.
- Lack of bone marrow or blood involvement by leukemia such as a documented CNS or testicular only relapse.
- 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.
- Patients with any known or suspected Hepatitis B, C and HIV infections.
- 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).
- Pregnant or lactating patients.
- 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.

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
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 |
Responsible Party: | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00983528 |
Other Study ID Numbers: |
090331 |
First Posted: | September 24, 2009 Key Record Dates |
Results First Posted: | August 12, 2020 |
Last Update Posted: | August 12, 2020 |
Last Verified: | July 2020 |
cancer lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Alemtuzumab Clofarabine Antineoplastic Agents, Immunological Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |