A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL, POETIC and ITCC

Phase 2

Completed

Conditions: Bone marrow and lymph node cancer
10024324

Registration Number: NL-OMON39457

Lead Sponsor: Children's Hopsital Los Angeles

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2

Inclusion Criteria

- Patients must be *1 and <18 years of age at the time of study enrollment (adpated for the NL)
- Patients must have T-cell ALL or T-cell lymphoblastic lymphoma (LL) in first relapse or must have failed primary induction chemotherapy
- ECOG 0-2 or Karnofsky * 50% for patients > 16 years of age; Lansky * 50% for patients *16 years of age. (See Appendix II for Performance Scales)
- Adequate renal function defined as serum creatinine * 1.5x upper limit of normal (ULN) for age. If the serum creatinine is above these values, the calculated creatinine clearance or radioisotope GFR must be * 70 mL/min/1.73m2.
- Total bilirubin * 1.5x ULN for age.
- If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin * ULN for age.
- ALT * 5x ULN of normal for age.
- Adequate cardiac function defined as shortening fraction of * 27% by echocardiogram or ejection fraction * 45% by gated radionuclide study.
- Patients must have adequate pulmonary function
- All patients and/or their parents or legal guardians must sign a written informed consent.

Exclusion Criteria

- Patients are excluded if they have CNS 3 disease
- Patients with Down syndrome are excluded.
- Patients with pre-existing Grade 2 (or greater) peripheral motor or sensory neurotoxicity per the CTCAE 3.0 as determined by the treating physician or a neurologist.
- Patients with a history of prior veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) or findings consistent with a diagnosis of VOD/SOS
- Patients are excluded if they have had
Previous hematopoietic stem cell transplantation;
Patients with a prior seizure disorder requiring anti-convulsants
- Patients are excluded if they have:
Positive blood culture within 48 hours of study enrollment;
Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection
- Plan to administer non-protocol chemotherapy, radiation therapy, immunotherapy, or any other investigational agents during the study period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For part I of the study: the recommended phase II dose of nelarabine in<br /><br>combination with cyclophosphamide and etoposide</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints for this study include CR2 and CR2p as defined in section<br /><br>10.1, and in addition:<br /><br>* For T-ALL patients achieving CR2, ability to proceed to HSCT within 20 weeks<br /><br>from study entry<br /><br>* Minimal residual disease (MRD) levels at the end of each course of therapy<br /><br>for T-ALL patients that attain CR2</p><br>