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Completed

NCT Number: NCT00199030

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

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.

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Key information

Conditions

Adult Acute Lymphocytic Leukemia T-cell Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Lymphoblastic Lymphoproliferative Disorders Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alemtuzumab (MabCampath)

Drug

cladribine

Drug

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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