NCT01658007

Pilot Study Of Sirolimus Plus Multiagent Chemotherapy For Relapsed/Refractory Acute Lymphoblastic Leukemia/Lymphoma

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The investigators want to learn about treating relapsed/refractory lymphoblastic leukemia and lymphoma with a drug called sirolimus. The investigators are using sirolimus along with other cancer drugs that are often given to patients with relapsed leukemia and lymphoma. The main purpose of this study is to determine if sirolimus can be given safely in combination with standard drugs used to treat relapsed lymphoblastic leukemia/lymphoma.

Detailed description

You will receive the drug sirolimus in addition to standard chemotherapy drugs. Just like your original cancer treatment, relapsed leukemia/lymphoma treatment is divided into different parts. You will get sirolimus during the first two parts: 1. Re-induction: We give chemotherapy drugs to try to put your cancer back into remission, meaning that no cancer cells are found in the bone marrow samples (if you have leukemia) or on imaging studies (if you have lymphoma). From start to finish, this part of therapy lasts 35 days. On this study, you will take the drug sirolimus daily in addition to the normal re-induction chemotherapy drugs. You will swallow liquid sirolimus and you must take it with food. You will take sirolimus three times on the first day and two times each day after that during re-induction. Altogether, this is the schedule for re-induction: * Sirolimus by mouth starting 7 days before standard re-induction starts, and continuing every day through day 28 * Mitoxantrone by vein on days 1 and 2 * Vincristine by vein on days 3, 10, 17 and 24 * Dexamethasone by vein or by mouth on days 1-5 and 15-19 * PEG-asparaginase\* on days 3 and 17 * IT Methotrexate given in spinal fluid on day 1 (all patients) day 8,29 (if no cancer found in spinal fluid) * IT Triples given in spinal fluid on days 8,15,22,29 (if cancer found in spinal fluid) (If you have an allergic reaction to PEG-asparaginase, you may be given 6 doses of Erwinia L-asparaginase instead) 2. Consolidation: We give drugs to continue to kill cancer cells in your body and prevent them from coming back. From start to finish, this part of therapy will last 63 days (it could be longer if we have to interrupt your treatment because you have low blood counts, and you need to wait for them to come up). On this study, you will take the drug sirolimus daily in addition to the normal consolidation chemotherapy drugs. You will take sirolimus three times on the first day and two times each day after that during consolidation. Altogether, this is the schedule for consolidation: * Sirolimus by mouth starting 7 days before consolidation starts, and continuing every day through day 56. * Cyclophosphamide by vein on days 1 and 29 * Cytarabine by vein or under skin on days 1-4, 8-11, 29-32, 36-39 * 6-mercaptopurine by mouth on days 1-14, 29-42 * PEG-asparaginase\* by vein on days 15 and 43 * Vincristine by vein on days 15 and 43 * It Methotrexate in spinal fluid on Days 1 and 29 3. After you complete re-induction and consolidation, your doctor will determine the next steps of your treatment. This will depend on how you are doing and it will be up to you and your doctor. It will not be part of this study. This research only includes the re-induction and consolidation portions of treatment (1 and 2, above). If you have already done re-induction, you can enter the study for consolidation only. In addition to all the regular tests and procedures done to check on your cancer during this study, we will also take additional blood samples to monitor the levels of sirolimus in your blood (in order to adjust your dose) and we will also take blood samples to find certain markers in your blood that might indicate that the sirolimus is doing what it is supposed to do.

Conditions

• Relapsed Lymphoblastic Leukemia
• Recurrent Adult Lymphoblastic Lymphoma
• Refractory Acute Lymphoblastic Leukemia
• Refractory Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Sirolimus	Adding sirolimus to established induction and consolidation chemotherapy for relapsed/refractory acute lymphoblastic leukemia

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2012-08-06
• Last updated: 2020-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study