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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Arm B | Experimental | In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alemtuzumab (MabCampath) | Drug |
| ||
| Cladribine |
| Measure | Description | 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 | 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 |
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Inclusion Criteria:
Both Arms:
Arm 1:
Arm 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Hoelzer, MD, PhD | University Hospital Frankfurt, Medical Dept. II | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Medical Dept. II | Frankfurt | 60590 | Germany |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D012008 | Recurrence |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D018365 | Neoplasm, Residual |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D017338 | Cladribine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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2 arms; Allocation by stratification
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|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |