Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Alemtuzumab (MabCampath)

Cladribine

About this trial

This is an interventional treatment trial for Adult Acute Lymphocytic Leukemia T-cell focused on measuring Relapse, T-ALL, T-LBL, MabCampath, Minimal residual disease, Lymphoma, lymphoblastic, T-cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital, Medical Dept. II

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A

Arm B

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00199030

First Posted

September 12, 2005

Last Updated

March 16, 2023

Sponsor

Goethe University

1. Study Identification

Unique Protocol Identification Number

NCT00199030

Brief Title

Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

February 2004 (Actual)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Goethe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Acute Lymphocytic Leukemia T-cell, Lymphoma, Lymphoblastic

Keywords

Relapse, T-ALL, T-LBL, MabCampath, Minimal residual disease, Lymphoma, lymphoblastic, T-cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

2 arms; Allocation by stratification

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm B

Arm Type

Experimental

Arm Description

In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation.

Intervention Type

Drug

Intervention Name(s)

Alemtuzumab (MabCampath)

Intervention Type

Drug

Intervention Name(s)

Cladribine

Primary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dieter Hoelzer, MD, PhD

Organizational Affiliation

University Hospital Frankfurt, Medical Dept. II

Official's Role

Study Chair

Facility Information:

Facility Name

University Hospital, Medical Dept. II

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Adult Acute Lymphocytic Leukemia T-cell, Lymphoma, Lymphoblastic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial