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

NCT00199030 | Completed Phase 2

• 1 other identifier: GMALL07
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Acute Lymphocytic Leukemia T-cell; Lymphoma, Lymphoblastic

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  after 1 Cycle - approximately 3 weeks

Study Arms (2)

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.

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.

Drug: Alemtuzumab (MabCampath)

Interventions

Alemtuzumab (MabCampath) DRUG

Arm A; Arm B

Cladribine DRUG

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual; Lymphoma

Interventions

Alemtuzumab; Cladribine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Dieter Hoelzer, MD, PhD

  University Hospital Frankfurt, Medical Dept. II

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of GMALL

Model Details: 2 arms; Allocation by stratification

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

DE (1)