Phase 2
N=3
Trial of Sirolimus and Methotrexate in Relapsed/Refractory Lymphoblastic Leukemia and Lymphoma
Cancer · Leukemia · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01162551 ↗Enrolled (actual)
3
Serious AEs
66.7%
Results posted
Aug 2019
Primary outcome: Primary: Response Rate — 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sirolimus and Methotrexate (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
0; 0; 0 | — |
| SECONDARY Number of Dose Adjustments To Maintain Trough Levels |
2; 1 | — |
Summary
This is a phase 2 study looking at efficacy and toxicity of oral sirolimus in combination with oral methotrexate in children with refractory/relapsed ALL or NHL.
Secondary objectives include characterizing the trough levels produced by administration of oral sirolimus in children with refractory/relapsed ALL/NHL and to evaluate the effect of sirolimus on intracellular targets related to mTOR inhibition.
Eligibility Criteria
Inclusion Criteria
- Patients 10% blasts in the marrow and for lymphoblastic lymphoma or peripheral T-cell lymphoma must have radiologic or physical evidence of recurrence.
- Lansky > 50% or Karnofsky > 50%
- Negative Pregnancy Test
- Creatinine clearance or radioisotope GFR > 70ml/min/m2 OR serum creatinine based on age /gender
- Pulse ox >94%
- Total Bilirubin 2g/dL
- Shortening fraction by echo > 28% OR ejection fraction > 50% by gated radionuclide study
Exclusion Criteria
- Patient has known allergies to sirolimus, FK-506 or mTOR inhibitors
- Patient is taking other investigational anti-neoplastic drugs
- Patient received no myelosuppressive chemo within 14 days
- 3 months must have elapsed
- Patient has uncontrolled infection (if patients with fungal disease, stable for grade 2
Use of steroids or hydroxyurea is permitted upto 14 days prior to entry.
Data sourced from ClinicalTrials.gov (NCT01162551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.