NCT02228772

Phase I Study of MLN 9708 in Addition to Chemotherapy for the Treatment of Acute Lymphoblastic Leukemia in Older Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 51 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a combination of drugs considered standard treatment for children and young adults with acute lymphoblastic leukemia (ALL), in combination with a new drug called MLN 9708. Additionally, the study is also evaluating if bone marrow or stem cell transplantation, which will be given to some participants, helps to prevent ALL from returning.

Detailed description

In this research study, the investigators are studying the optimal dose of the drug MLN 9708 when given with a standard multi-drug regimen. In the first part of the study, up to 18 participants will be enrolled at different doses of MLN 9708. Once the maximally tolerated (highest, safest dose) is established, an additional 10 participants will be enrolled. Additionally, bone marrow (tissue found in the inside of bones) or stem cell transplantation will be given to some participants to study whether it helps to prevent ALL from returning. The study treatment consists of several different stages * Induction * Consolidation 1 * Or Stem Cell or Bone Marrow Transplant (if you are eligible based on your medical condition and the availability of a matched stem cell donor) * Or If you do not have a transplant: * CNS Therapy * Consolidation 2 * Continuation Therapy

Conditions

• Acute Lymphoblastic Leukemia
• Lymphoblastic Lymphoma
• B-cell Adult Acute Lymphoblastic Leukemia
• T-cell Adult Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	MLN 9708	Patients will received standard chemotherapy as well as MLN 9708 in escalating doses.
DRUG	Vincristine	Standard chemotherapy dosage and duration
DRUG	Cytarabine	Standard chemotherapy dosage and duration
DRUG	Doxorubicin	Standard chemotherapy dosage and duration
DRUG	Mercaptopurine	Standard chemotherapy dosage and duration
DRUG	Cyclophosphamide	Standard chemotherapy dosage and duration
DRUG	Methotrexate	Standard chemotherapy dosage and duration

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-10-01
• Completion: 2019-11-01
• First posted: 2014-08-29
• Last updated: 2019-11-26

Locations

3 sites across 1 country: United States