Adult Acute Lymphocytic Leukemia T-cellPhase 2NCT00199030
Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath
A Phase 2 study testing Alemtuzumab (MabCampath) and Cladribine in people with Adult Acute Lymphocytic Leukemia T-cell and Lymphoma, Lymphoblastic, run by Goethe University at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Acute Lymphocytic Leukemia T-cell, Lymphoma, Lymphoblastic
- What is being tested?
- Alemtuzumab (MabCampath) and Cladribine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2004to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- Extramedullary bulky disease
- Active secondary malignancies
- Pregnancy or nursing
- Mental disease or circumstances that prohibit compliance with the protocol procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Alemtuzumab (MabCampath), Cladribine
- Keywords
- Relapse, T-ALL, T-LBL, MabCampath, Minimal residual disease, Lymphoma, lymphoblastic, T-cell
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alemtuzumab (MabCampath)Drug
CladribineDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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. Receives: Drug: Alemtuzumab (MabCampath); Drug: Cladribine |
| Arm B | Experimental | In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation. Receives: Drug: Alemtuzumab (MabCampath) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: after 1 Cycle - approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Lymphocytic Leukemia T-cellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms; Allocation by stratification
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Goekbuget, Goethe University
- Investigators
- Dieter Hoelzer, MD, PhD, Study chair, University Hospital Frankfurt, Medical Dept. II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199030
- Sponsor's protocol ID
- GMALL07
- Status last verified
- Mar 2023
- First submitted
- 12 Sep 2005
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00199030
- Acronym / sponsor ID
- GMALL07
- Keywords
- Relapse, T-ALL, T-LBL, MabCampath, Minimal residual disease, Lymphoma, lymphoblastic, T-cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Feb 2004 (actual)
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms; Allocation by stratification
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Alemtuzumab (MabCampath), Drug: CladribineIn 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. |
| Arm B | Experimental | Drug: Alemtuzumab (MabCampath)In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alemtuzumab (MabCampath) | Drug | Arm A, Arm B |
| Cladribine | Drug | Arm A |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
Related trials for Adult Acute Lymphocytic Leukemia T-cell
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Hoelzer, MD, PhD study chair
University Hospital Frankfurt, Medical Dept. II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alemtuzumab (MabCampath) and Cladribine in people with Adult Acute Lymphocytic Leukemia T-cell and Lymphoma, Lymphoblastic, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.