Numerous clinical trials encompassing Phase 1 safety, Phase 2 efficacy, and Phase 3 randomized studies have evaluated nelarabine in hematologic malignancies, predominantly T-cell acute lymphoblastic leukemia and T-lymphoblastic lymphoma. Sponsored by academic medical centers, cooperative networks—including M.D. Anderson Cancer Center and the Children's Oncology Group—and pharmaceutical companies, these completed, active, and planned protocols investigate combination chemotherapy regimens and risk-adapted consolidation.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07072585 | NOT_YET_RECRUITING | Stage II T Lymphoblastic Leukemia/Lymphoma; Stage III T Lymphoblastic Leukemia/Lymphoma; Stage IV T Lymphoblastic Leukemia/Lymphoma; T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma |
Children's Oncology Group |
2026-08-28 | PHASE2; PHASE3 |
| NCT07294677 | RECRUITING | Leukemia; Lymphoma |
University of Chicago |
2026-03-17 | PHASE1; PHASE2 |
| NCT06390319 | RECRUITING | T-cell Acute Lymphoblastic Leukemia; T-cell Lymphoma; Mixed Phenotype Acute Leukemia |
St. Jude Children's Research Hospital |
2024-12-27 | PHASE2 |
| NCT03020030 | ACTIVE_NOT_RECRUITING | Acute Lymphoblastic Leukemia, Pediatric |
Dana-Farber Cancer Institute |
2017-03-03 | PHASE3 |
| NCT00501826 | RECRUITING | T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma |
M.D. Anderson Cancer Center |
2007-07-11 | PHASE2 |
| NCT03117751 | ACTIVE_NOT_RECRUITING | Acute Lymphoblastic Leukemia; Acute Lymphoblastic Lymphoma |
St. Jude Children's Research Hospital |
2017-03-29 | PHASE2; PHASE3 |
| NCT06210750 | WITHDRAWN | T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma |
National Cancer Institute (NCI) |
2024-08-09 | PHASE2 |
| NCT03808610 | TERMINATED | Recurrent B Acute Lymphoblastic Leukemia; Recurrent T Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia; Refractory T Acute Lymphoblastic Leukemia |
M.D. Anderson Cancer Center |
2019-04-03 | PHASE1; PHASE2 |
| NCT06434467 | UNKNOWN | T-lymphoblastic Leukemia; T-lymphoblastic Lymphoma |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2024-05 | PHASE3 |
| NCT02881086 | COMPLETED | Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma |
Goethe University |
2016-08 | PHASE3 |
| NCT03328104 | COMPLETED | Lymphoblastic Leukemia; Lymphoblastic Lymphoma |
Emory University |
2018-07-24 | PHASE1 |
| NCT02763384 | TERMINATED | T-Acute Lymphoblastic Leukemia; Adult T Lymphoblastic Lymphoma |
Washington University School of Medicine |
2016-12-02 | PHASE2 |
| NCT02619630 | UNKNOWN | T-cell Adult Acute Lymphoblastic Leukemia |
Assistance Publique - Hôpitaux de Paris |
2015-12 | PHASE2 |
| NCT01094860 | COMPLETED | Leukemia |
M.D. Anderson Cancer Center |
2010-06-08 | PHASE1 |
| NCT02518750 | TERMINATED | Acute Lymphoblastic Leukemia; Lymphoma, Non-Hodgkin's; Leukemia, T-Cell; Leukemia, B-Cell |
St. Jude Children's Research Hospital |
2016-11-23 | PHASE2 |
| NCT00408005 | COMPLETED | T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma |
National Cancer Institute (NCI) |
2007-01-30 | PHASE3 |
| NCT02619630 | Recruiting | T-cell Adult Acute Lymphoblastic Leukemia |
Assistance Publique - Hôpitaux de Paris |
2015-12 | Phase 2 |
| NCT00981799 | TERMINATED | Relapsed T-Cell Acute Lymphoblastic Leukemia; Relapsed T-Cell Lymphoblastic Lymphoma |
Therapeutic Advances in Childhood Leukemia Consortium |
2010-06 | PHASE1; PHASE2 |
| NCT01094860 | Completed | Leukemia |
M.D. Anderson Cancer Center|GlaxoSmithKline |
2010-06-08 | Phase 1 |
| NCT00406757 | COMPLETED | Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic |
GlaxoSmithKline |
2006-08-30 | PHASE1 |
| NCT00684619 | COMPLETED | T-ALL, T-NHL (Lymphoblastic) |
Goethe University |
2003-06 | PHASE2 |
| NCT01376115 | Completed | Cancer |
Novartis Pharmaceuticals|Novartis |
2008-01-18 | -- |
| NCT00016302 | COMPLETED | T-cell Childhood Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia |
National Cancer Institute (NCI) |
2001-04 | |
| NCT00003545 | COMPLETED | Leukemia; Lymphoma |
National Cancer Institute (NCI) |
1998-08 | PHASE2 |
| NCT00005080 | COMPLETED | Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Small Intestine Lymphoma; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage I Mycosis Fungoides/Sezary Syndrome; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Mycosis Fungoides/Sezary Syndrome; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome |
National Cancer Institute (NCI) |
2000-05 | PHASE2 |
| NCT00002970 | COMPLETED | Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Lymphoblastic Lymphoma; T-cell Childhood Acute Lymphoblastic Leukemia |
National Cancer Institute (NCI) |
1997-06 | PHASE2 |
| NCT00005950 | TERMINATED | Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma; Waldenström Macroglobulinemia |
National Cancer Institute (NCI) |
2000-04 | PHASE2 |
| NCT00005982 | TERMINATED | Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome |
National Cancer Institute (NCI) |
2000-04 | PHASE2 |
| NCT00006020 | COMPLETED | Leukemia |
SWOG Cancer Research Network |
2000-07 | PHASE2 |
| NCT00003635 | COMPLETED | Leukemia |
GlaxoSmithKline |
1999-01 | PHASE2 |
| NCT00003837 | COMPLETED | Leukemia; Lymphoma |
National Cancer Institute (NCI) |
1999-09 |
(data from https://clinicaltrials.gov, updated on 2026-07-30)
Check the
Nelarabine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.