- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00199030
Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath
March 16, 2023 updated by: Nicola Goekbuget, Goethe University
German Multicenter Phase II Trial to Study Effectivity and Feasibility of Alemtuzumab (MabCampath®) in T-ALL and T-Lymphoblastic Lymphomas With Minimal Residual Disease (MRD), in Refractory Relapse or in Primary Failure
This study tests the effectivity and tolerability of treatment with alemtuzumab (MabCampath) in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma.
In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation.
In case of insufficient response, treatment with cladribine is added.
In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation.
In both arms, treatment is continued in case of response for up to two months.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Frankfurt, Germany, 60590
- University Hospital, Medical Dept. II
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Both Arms:
- T-ALL or T-lymphoblastic lymphoma
- CD52-expression > 20%
- Aged >= 18 years
- ECOG/World Health Organization (WHO) performance status 0-2
- Life expectancy of > 2 months
- Contraception during, and for at least 6 months after, therapy
- At least a 2 week interval to the last cycle of chemotherapy (decision in individual cases if rapid progression)
- No persistent toxicity from earlier cycles
- Written informed consent
Arm 1:
- Evidence of MRD > 10(-4) with confirmation beyond week 16 in the GMALL-Study 07/2003
Arm 2:
- Relapse with failure to at least one salvage therapy or primary failure after induction therapy and at least one salvage therapy
Exclusion Criteria:
- Substantial restrictions of heart, lung, liver, or kidney function
- Active infection, HIV seropositivity or cytomegalovirus (CMV) viraemia
- Pretreatment with MabCampath®
- Known anaphylaxis to humanised antibodies
- Permanent systemic therapy with corticosteroids
- Central nervous system (CNS) involvement
- Extramedullary bulky disease
- Active secondary malignancies
- Pregnancy or nursing
- Mental disease or circumstances that prohibit compliance with the protocol procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation.
In case of insufficient response, treatment with cladribine is added.
|
|
Experimental: Arm B
In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arm A: rate of molecular remissions (MRD < 10(-4), toxicity according to CTC, remission duration/survival, feasibility of s.c. dose escalation and long term therapy, mortality
Time Frame: after 1 cycle - approximately 3 weeks
|
after 1 cycle - approximately 3 weeks
|
Arm B: response (CR/PR/MR), toxicity according to CTC, SCT rate, remission duration/survival, feasibility of i.v. dose escalation/long term therapy, mortality
Time Frame: after 1 Cycle - approximately 3 weeks
|
after 1 Cycle - approximately 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2004
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Actual)
March 20, 2023
Last Update Submitted That Met QC Criteria
March 16, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Lymphoma
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Cladribine
- Alemtuzumab
Other Study ID Numbers
- GMALL07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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