Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H (NSC #715969, IND #10864) During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia (ALL)
5 other identifiers
interventional
302
1 country
1
Brief Summary
This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing. Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2003
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 5, 2003
CompletedFirst Posted
Study publicly available on registry
June 6, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
April 16, 2014
CompletedMay 3, 2022
April 1, 2022
4.5 years
June 5, 2003
December 5, 2013
April 5, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)
The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.
6 weeks
Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)
The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.
8 months
Secondary Outcomes (3)
Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II)
9 years 4 months
Disease-free Survival, for Only Complete Response Patients
9 years 4 months
Overall Survival
9 years 4 months
Study Arms (1)
Treatment (alemtuzumab and combination chemotherapy)
EXPERIMENTALSee detailed description.
Interventions
Correlative studies
Eligibility Criteria
You may qualify if:
- Unequivocal histologic diagnosis of precursor B or precursor T lymphoblastic leukemia (World Health Organization \[WHO\] classification), L1 or L2 ALL or acute undifferentiated leukemia (AUL) (French-American-British Cooperative group \[FAB\] Classification); Burkitt-type ALL (FAB L3, surface immunoglobulin \[SIg\]+) are excluded
- No prior treatment for leukemia with three permissible exceptions:
- Emergency leukapheresis II. Emergency treatment for hyperleukocytosis with hydroxyurea III. Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
- All patients must have a pre-treatment bone marrow or peripheral blood sample submitted for central immunophenotyping; only those patients who express CD52 \>= 10% in the leukemia blast cell channel will be eligible to receive Campath-1H during module D, course IV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer and Leukemia Group B
Chicago, Illinois, 60606, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Stock, M.D.
- Organization
- University of Chicago Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy Stock
Cancer and Leukemia Group B
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2003
First Posted
June 6, 2003
Study Start
June 1, 2003
Primary Completion
December 1, 2007
Study Completion
October 1, 2012
Last Updated
May 3, 2022
Results First Posted
April 16, 2014
Record last verified: 2022-04