Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML1107)
This study is ongoing, but not recruiting participants.
Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00775593
First received: October 17, 2008
Last updated: January 18, 2012
Last verified: January 2012
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Purpose
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: clofarabine Drug: temsirolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) |
Resource links provided by NLM:
Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Primary Outcome Measures:
- Complete response rate [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tolerability and safety [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: Yes ]
- Duration of response [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
- Duration of survival [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: clofarabine
Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction.
Induction therapy
- Clofarabine 20 mg/m2/day, administered by iv infusion over 1 hour on days 1 through 5
Those who achieve morphologic CR and morphologic CRi will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse.
Those who achieve a PR will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above.
Induction therapy:
- Temsirolimus 25 mg (flat dose) administered iv over 30 minutes on days 1, 8 and 15.
Maintenance therapy:
- Temsirolimus 25 mg (flat dose) administered iv over 30 minutes on days 1 and 8 of each month for 12 months, or until relapse.
OBJECTIVES:
Primary
- To determine the complete response rate in older patients with relapsed or refractory acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus.
Secondary
- To determine the tolerability and safety of this regimen.
- To determine the duration of response.
- To determine the duration of survival.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment continues for 1-2 courses in the absence of disease progression or unacceptable toxicity.
- Maintenance therapy: Patients achieving morphologic complete remission (CR) or CR with incomplete blood count recovery receive temsirolimus IV over 30 minutes on days 1 and 8 of each month. Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:
- At least 20% of blasts in the bone marrow
- AML in first relapse OR refractory to no more than one prior combination chemotherapy induction regimen
- No acute promyelocytic leukemia
- No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
- No active CNS leukemia
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 4 weeks
- Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)*
- AST and ALT ≤ 2.5 times ULN*
- Serum creatinine ≤ 1.0 mg/dL* OR estimated glomerular filtration rate > 60 mL/min
- No active uncontrolled systemic infection
- No concurrent active malignancy
- No HIV positivity
- No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: *Unless due to organ leukemic involvement
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior myelosuppressive chemotherapy
- At least 48 hours since prior hydroxyurea
- No prior clofarabine or temsirolimus
- No prior allogeneic stem cell transplantation
- No investigational drug within the past 30 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775593
Locations
| Italy | |
| Azienda ospedaliera Nuovo ospedale "Torrette" | |
| Ancona, Italy | |
| Azienda Ospedaliero-Universitaria Policlinico Consorziale | |
| Bari, Italy | |
| Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi | |
| Bologna, Italy, 40138 | |
| Ospedale Ferrarotto | |
| Catania, Italy, 95124 | |
| Ospedale Regionale A. Pugliese | |
| Catanzaro, Italy, 88100 | |
| Azienda ospedaliera di Rilievo Nazionale "A. Cardarelli" | |
| Napoli, Italy | |
| Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia | |
| Napoli, Italy | |
| S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro | |
| Novara, Italy | |
| A.O. Universitaria S. Luigi Gonzaga di Orbassano | |
| Orbassano, Italy | |
| Azienda Ospedaliero - Universitaria di Parma | |
| Parma, Italy | |
| Azienda ASL di Pescara | |
| Pescara, Italy, 61100 | |
| Complesso Ospedaliero S. Giovanni Addolorata | |
| Roma, Italy | |
| S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena | |
| Roma, Italy | |
| Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia | |
| Roma, Italy | |
| Ospedale S. Eugenio | |
| Roma, Italy | |
| Policlinico di Tor Vergata | |
| Rome, Italy, 00133 | |
| Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | |
| Rome, Italy, 00168 | |
| Serv. di Ematologia Ist. di Ematologia ed Endocrinologia | |
| Sassari, Italy | |
| Policlinico G. B. Rossi - Borgo Roma | |
| Verona, Italy, 37134 | |
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
| Principal Investigator: | Sergio Amadori, MD | Ospedale Sant' Eugenio |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| ClinicalTrials.gov Identifier: | NCT00775593 History of Changes |
| Other Study ID Numbers: | AML1107, GIMEMA-AML-1107, EUDRACT-2007-005374-31, EU-20886, WYETH-GIMEMA-AML-1107 |
| Study First Received: | October 17, 2008 |
| Last Updated: | January 18, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
|
recurrent adult acute myeloid leukemia adult acute basophilic leukemia adult acute eosinophilic leukemia adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) |
adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with inv(16)(p13;q22) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Sirolimus Everolimus Clofarabine Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 21, 2013