Biology and Treatment Strategy of AML in Its Subgroups: Multicenter Randomized Trial by the German Acute Myeloid Leukemia Cooperative Group (AMLCG)
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| ClinicalTrials.gov Identifier: NCT00266136 |
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Recruitment Status :
Completed
First Posted : December 15, 2005
Last Update Posted : October 26, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Myeloid Leukemia | Drug: Cytarabine Drug: Thioguanine Drug: Daunorubicin Drug: Cyclophosphamide Drug: G-CSF Procedure: Autologous stem cell transplantation Procedure: Allogeneic stem cell transplantation | Phase 3 |
The present study by the German AML Cooperative Group has been designed in order to investigate the effects of AML typical therapeutic strategies for AML and related diseases. Thus, the entry criteria are age starting from 16 years with no upper age limit, de novo AML or AML secondary to chemotherapy or radiotherapy of another disease or myelodysplasia subtype RAEB with bone marrow blasts greater than 10 %. All randomization is stratified according to karyotype favorable / intermediate / unfavorable. Additional stratification is according to LDH </>= 700 U and age </>= 60 Y. Standard treatment is (A) double induction with TAD and HAM, consolidation with TAD and maintenance treatment with monthly AD-AT-AC-AT -, rotatingly. Experimental modifications to be compared with stan-dard treatment are (B) double induction with HAM-HAM, (C) multiple course G-CSF before and during chemotherapy courses and (D) instead of maintenance treatment myeloablative consolidation with Bu/Cy and autologous blood stem cell transplantation. Intent to treat conditions are guaranteed by randomization before induction treatment starts. In order to evaluate the effect of every single modification randomization to (C) is equally distributed to the patients in treatment arms (A) and (B) which is also true for the randomization to (D) (balanced randomization). Similarly balanced between treatment arms are the patients according to diagnosis, age and risk factors like serum LDH and karyotype. In order to adapt treatment intensity to age patients of 60 years and older receive the second induction course only in case of 5 % or more residual bone marrow blasts. In addition, the AraC dose in HAM is reduced to 1 instead of 3 g/sqm in this age group. Furthermore, there is no treatment arm including stem cell transplantation in patients of 60+ years. Pri-mary endpoint to compare the therapeutic strategies is event-free survival from treatment start (A, B, C) and from achievement of remission (D), respectively.
By this design the AMLCG 2000 trial can contribute relevant experiences on optimum therapeutic strategies for the biological subgroups of de novo AML, secondary AML and MDS. Furthermore, new biological subgroups and their significance related to treatment strategies can be defined.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3500 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Risk-stratified Therapy for Primary and Secondary AML and MDS. A Randomized Study by AMLCG in Relation to Cytogenetically Defined Prognostic Factors (1) on the Role of High-dose AraC as Part of Double Induction, (2) on G-CSF Priming, and (3) on High-dose Chemotherapy With Stem Cell Transplantation |
| Study Start Date : | June 1999 |
| Actual Primary Completion Date : | January 2007 |
| Actual Study Completion Date : | October 2012 |
- Drug: Cytarabine
see protocol
- Drug: Thioguanine
see protocol
- Drug: Daunorubicin
see protocol
- Drug: Cyclophosphamide
see protocol
- Drug: G-CSF
see protocol
- Procedure: Autologous stem cell transplantation
for details see protocol
- Procedure: Allogeneic stem cell transplantation
for details see protocol
- Remission rate, Remission duration,Relapse-free survival, Overall survival, Event-free survival [ Time Frame: 12-18months ]
- Time and dose compliance, Realisation of SCT, Toxicity according to WHO [ Time Frame: 12-18months ]
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Acute myeloid leukemia (de-novo AML, secondary AML, high-risk MDS)
- Age 16 - no upper age limit
- Written informed consent
Exclusion Criteria:
- Severe comorbidity
- Presence of other malignancy
- Prior anti-leukemic treatment
- Pregnancy
- Severe psychiatric disorder or other circumstances which may compromise cooperation of the patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266136
| Germany | |
| University of Muenster, Medical Center, Department of Medicine, Hematology and Oncology | |
| Muenster, Germany, 48129 | |
| Study Chair: | Thomas Buechner, MD PhD | University of Muenster, Medical Center, Department of Medicine, Hematology and Oncology |
| Responsible Party: | Prof. Dr. Thomas Büchner, Prof. Dr. Thomas Büchner MD PhD, University Hospital Muenster, University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT00266136 |
| Other Study ID Numbers: |
AMLCG 99 BMBF 01 GI 02070 |
| First Posted: | December 15, 2005 Key Record Dates |
| Last Update Posted: | October 26, 2012 |
| Last Verified: | October 2012 |
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AML treatment, de-novo, secondary, high-risk MDS, chemotherapy, autologous SCT, adult |
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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Cytarabine Cyclophosphamide Daunorubicin Thioguanine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |