Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT00775593 | Completed Phase 2 Results

• 3 other identifiers: AML1107GIMEMA-AML-1107EUDRACT-2007-005374-31
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Leukemia

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  At 2 years from study entry

Secondary Outcomes (3)

• Number of Serious Adverse Events Within 2 Years

  At 2 years from study entry

• Duration of Response

  At 2 years from study entry

• Duration of Survival

  At 2 years from study entry

Interventions

clofarabine DRUG

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

temsirolimus DRUG

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 of intensive 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (19)

Azienda ospedaliera Nuovo ospedale "Torrette"

Ancona, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Consorziale

Bari, Italy

Location

Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi

Bologna, 40138, Italy

Location

Ospedale Ferrarotto

Catania, 95124, Italy

Location

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

Location

Azienda ospedaliera di Rilievo Nazionale "A. Cardarelli"

Napoli, Italy

Location

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

Napoli, Italy

Location

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, Italy

Location

A.O. Universitaria S. Luigi Gonzaga di Orbassano

Orbassano, Italy

Location

Azienda Ospedaliero - Universitaria di Parma

Parma, Italy

Location

Azienda ASL di Pescara

Pescara, 61100, Italy

Location

Complesso Ospedaliero S. Giovanni Addolorata

Roma, Italy

Location

Ospedale S. Eugenio

Roma, Italy

Location

S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena

Roma, Italy

Location

Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

Roma, Italy

Location

Policlinico di Tor Vergata

Rome, 00133, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

Sassari, Italy

Location

Policlinico G. B. Rossi - Borgo Roma

Verona, 37134, Italy

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Congenital Abnormalities

Interventions

Clofarabine; temsirolimus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides

Results Point of Contact

• Title: Edoardo La Sala
• Organization: GIMEMA

e.lasala@gimema.it

+39 06 70390524

Study Officials

• Sergio Amadori, MD

  Ospedale Sant' Eugenio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: October 23, 2013
• Last Updated: November 9, 2017
• Results First Posted: March 23, 2015

Record last verified: 2017-10

Locations

IT (19)