Pralatrexate has been evaluated across numerous clinical trials spanning Phase 1 to Phase 4 development, encompassing completed, active, recruiting, and terminated studies. Sponsored by both industry entities and academic institutions, these trials primarily investigate hematologic malignancies—such as peripheral and cutaneous T-cell lymphomas, Hodgkin and non-Hodgkin lymphomas, and multiple myeloma—alongside advanced solid tumors and transitional cell bladder carcinoma.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07225985 | RECRUITING | Recurrent T-Cell Non-Hodgkin Lymphoma; Refractory T-Cell Non-Hodgkin Lymphoma |
Fred Hutchinson Cancer Center |
2026-04-27 | PHASE1; PHASE2 |
| NCT06072131 | RECRUITING | Peripheral T Cell Lymphoma |
Acrotech Biopharma Inc. |
2023-10-04 | PHASE3 |
| NCT07691450 | NOT_YET_RECRUITING | Recurrent Anaplastic Large Cell Lymphoma; Recurrent Enteropathy-Associated T-Cell Lymphoma; Recurrent Follicular Helper T-Cell Lymphoma; Recurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type; Recurrent Follicular Helper T-Cell Lymphoma, Follicular-Type; Recurrent Follicular Helper T-Cell Lymphoma, Not Otherwise Specified; Recurrent Hepatosplenic T-Cell Lymphoma; Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Recurrent Monomorphic Epitheliotropic Intestinal T-cell Lymphoma; Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified; Recurrent Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell Lymphoma; Recurrent Primary Cutaneous Gamma-Delta T-Cell Lymphoma; Recurrent Subcutaneous Panniculitis-Like T-Cell Lymphoma; Refractory Anaplastic Large Cell Lymphoma; Refractory Enteropathy-Associated T-Cell Lymphoma; Refractory Follicular Helper T-Cell Lymphoma; Refractory Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type; Refractory Follicular Helper T-Cell Lymphoma, Follicular-Type; Refractory Follicular Helper T-Cell Lymphoma, Not Otherwise Specified; Refractory Hepatosplenic T-Cell Lymphoma; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Refractory Monomorphic Epitheliotropic Intestinal T-cell Lymphoma; Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified; Refractory Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell Lymphoma; Refractory Primary Cutaneous Gamma-Delta T-Cell Lymphoma; Refractory Subcutaneous Panniculitis-Like T-Cell Lymphoma |
City of Hope Medical Center |
2027-01-03 | PHASE1 |
| NCT04747236 | RECRUITING | PTCL |
University of Virginia |
2021-02-19 | PHASE2 |
| NCT06561048 | RECRUITING | Peripheral T-Cell Lymphoma, Not Otherwise Specified; Angioimmunoblastic T-cell Lymphoma; Follicular T-Cell Lymphoma; Nodal Peripheral T-Cell Lymphoma With TFH Phenotype; Systemic Anaplastic Large Cell Lymphoma; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell |
Corvus Pharmaceuticals, Inc. |
2024-10-02 | PHASE3 |
| NCT06671717 | NOT_YET_RECRUITING | Relapsed Peripheral T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma |
Peking University People's Hospital |
2024-12 | |
| NCT07036133 | RECRUITING | Advanced Solid Tumors; Hematologic Malignancies |
Acrotech Biopharma Inc. |
2022-12-28 | PHASE1 |
| NCT03240211 | ACTIVE_NOT_RECRUITING | PTCL; CTCL |
University of Virginia |
2022-02-02 | PHASE1 |
| NCT03598998 | ACTIVE_NOT_RECRUITING | Anaplastic Large Cell Lymphoma; Nodal Peripheral T-Cell Lymphoma With TFH Phenotype; Recurrent Anaplastic Large Cell Lymphoma; Recurrent Angioimmunoblastic T-Cell Lymphoma; Recurrent Enteropathy-Associated T-Cell Lymphoma; Recurrent Follicular Lymphoma; Recurrent Hepatosplenic T-Cell Lymphoma; Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma; Recurrent Monomorphic Epitheliotropic Intestinal T-cell Lymphoma; Recurrent Mycosis Fungoides; Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified; Refractory Anaplastic Large Cell Lymphoma; Refractory Angioimmunoblastic T-Cell Lymphoma; Refractory Enteropathy-Associated T-Cell Lymphoma; Refractory Follicular Lymphoma; Refractory Hepatosplenic T-Cell Lymphoma; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Refractory Mycosis Fungoides; Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified; Subcutaneous Panniculitis-Like T-Cell Lymphoma |
City of Hope Medical Center |
2019-02-04 | PHASE1; PHASE2 |
| NCT03161223 | RECRUITING | Lymphoma, T-Cell |
University of Virginia |
2018-05-30 | PHASE1; PHASE2 |
| NCT01947140 | COMPLETED | Lymphoid Malignancies; Multiple Myeloma; Lymphoma; Hodgkin Lymphoma; Non-hodgkin Lymphoma |
Jennifer Amengual |
2013-09-09 | PHASE1; PHASE2 |
| NCT03150602 | UNKNOWN | Peripheral T Cell Lymphoma; Progression, Disease |
Taiwan Mundipharma Pharmaceuticals Ltd. |
2016-08-30 | PHASE4 |
| NCT03355768 | WITHDRAWN | Lymphoma, T-Cell, Peripheral |
Jennifer Amengual |
2018-09-01 | PHASE3 |
| NCT02106650 | COMPLETED | Relapsed Peripheral T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma |
Acrotech Biopharma Inc. |
2014-07 | PHASE2 |
| NCT01420679 | TERMINATED | Peripheral T-cell Lymphoma |
Spectrum Pharmaceuticals, Inc |
2011-08 | PHASE3 |
| NCT03349333 | COMPLETED | Refractory Peripheral T-Cell Lymphoma; Relapsed T-Cell Lymphoma |
Mundipharma (China) Pharmaceutical Co. Ltd |
2015-09-10 | PHASE3 |
| NCT02594267 | COMPLETED | Peripheral T-Cell Lymphoma (PTCL) |
Acrotech Biopharma Inc. |
2015-11-10 | PHASE1 |
| NCT01336933 | COMPLETED | Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Hepatosplenic T-cell Lymphoma; Peripheral T-cell Lymphoma |
University of Nebraska |
2011-07-06 | PHASE2 |
| NCT01188876 | COMPLETED | Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer |
Massachusetts General Hospital |
2010-08 | PHASE1; PHASE2 |
| NCT01532011 | COMPLETED | Advanced Cancers; Solid Tumors |
M.D. Anderson Cancer Center |
2012-03 | PHASE1 |
| NCT02013362 | COMPLETED | Peripheral T-cell Lymphoma |
Mundipharma K.K. |
2014-03 | PHASE1; PHASE2 |
| NCT02594267 | Completed | Peripheral T-Cell Lymphoma (PTCL) |
Acrotech Biopharma Inc.|Axis Clinicals Limited |
2015-11-10 | Phase 1 |
| NCT01134341 | COMPLETED | Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome; Primary Cutaneous Anaplastic Large Cell Lymphoma |
Acrotech Biopharma Inc. |
2010-03 | PHASE1 |
| NCT01626664 | COMPLETED | Adult T-cell Leukemia-Lymphoma |
Kyowa Kirin, Inc. |
2012-06 | PHASE2 |
| NCT01482962 | COMPLETED | Relapsed Peripheral T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma |
Millennium Pharmaceuticals, Inc. |
2012-06-11 | PHASE3 |
| NCT01820091 | WITHDRAWN | Non-Small Cell Lung Cancer |
Acrotech Biopharma Inc. |
2013-04 | PHASE1 |
| NCT01789723 | WITHDRAWN | Non Hodgkin's Lymphoma |
Acrotech Biopharma Inc. |
2013-03 | PHASE1 |
| NCT01206465 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
University of Nebraska |
2010-09-14 | PHASE1 |
| NCT01178944 | COMPLETED | Adenocarcinoma of the Gastroesophageal Junction; Esophageal Undifferentiated Carcinoma; Gastric Adenocarcinoma; Gastric Squamous Cell Carcinoma; Recurrent Esophageal Adenocarcinoma; Recurrent Esophageal Squamous Cell Carcinoma; Recurrent Gastric Carcinoma; Stage IIIB Esophageal Adenocarcinoma; Stage IIIB Esophageal Squamous Cell Carcinoma; Stage IIIB Gastric Cancer; Stage IIIC Esophageal Adenocarcinoma; Stage IIIC Esophageal Squamous Cell Carcinoma; Stage IIIC Gastric Cancer; Stage IV Esophageal Adenocarcinoma; Stage IV Esophageal Squamous Cell Carcinoma; Stage IV Gastric Cancer; Undifferentiated Gastric Carcinoma |
Roswell Park Cancer Institute |
2010-09 | PHASE2 |
| NCT01183065 | COMPLETED | Head and Neck Cancer |
Memorial Sloan Kettering Cancer Center |
2010-08 | PHASE2 |
| NCT01114282 | COMPLETED | Multiple Myeloma |
Stanford University |
2010-08 | PHASE1 |
| NCT01947140 | Completed | Lymphoid Malignancies|Multiple Myeloma|Lymphoma|Hodgkin Lymphoma|Non-hodgkin Lymphoma |
Jennifer Amengual|Columbia University |
2013-09-09 | Phase 1|Phase 2 |
| NCT01129206 | COMPLETED | Adenocarcinoma of the Esophagus; Adenocarcinomas of the Gastroesophageal Junction; Recurrent Esophageal Cancer; Squamous Cell Carcinoma of the Esophagus; Stage IV Esophageal Cancer |
Ohio State University Comprehensive Cancer Center |
2010-07 | PHASE2 |
| NCT00998946 | COMPLETED | Lymphoma, B-Cell |
Spectrum Pharmaceuticals, Inc |
2009-09 | PHASE2 |
| NCT01118624 | COMPLETED | Breast Cancer; Breast Tumors; Neoplasms, Breast; Cancer of the Breast; Human Mammary Carcinoma |
Acrotech Biopharma Inc. |
2010-03 | PHASE2 |
| NCT01532011 | Completed | Advanced Cancers|Solid Tumors |
M.D. Anderson Cancer Center |
2012-03 | Phase 1 |
| NCT00554827 | COMPLETED | Cutaneous T-cell Lymphoma |
Acrotech Biopharma Inc. |
2007-08 | PHASE1 |
| NCT00481871 | COMPLETED | Relapsed or Refractory Lymphoproliferative Malignancies; Hodgkin's Lymphoma; Peripheral T-cell Lymphoma; B-cell Lymphoma; Waldenstrom's Macroglobulinemia |
Acrotech Biopharma Inc. |
2007-05 | PHASE1; PHASE2 |
| NCT00722553 | COMPLETED | Carcinoma, Transitional Cell; Bladder Cancer; Bladder Neoplasm |
Acrotech Biopharma Inc. |
2008-07 | PHASE2 |
| NCT01114282 | Completed | Multiple Myeloma |
Stanford University|National Comprehensive Cancer Network |
2010-08 | Phase 1 |
| NCT00606502 | COMPLETED | Non-small Cell Lung Cancer |
Spectrum Pharmaceuticals, Inc |
2008-01 | PHASE2 |
| NCT00052442 | COMPLETED | Lymphoma |
Spectrum Pharmaceuticals, Inc |
2002-08 | PHASE1; PHASE2 |
| NCT00364923 | COMPLETED | Peripheral T-cell Lymphoma |
Acrotech Biopharma Inc. |
2006-08 | PHASE2 |
| NCT00004238 | COMPLETED | Lung Cancer |
Memorial Sloan Kettering Cancer Center |
1999-07 | PHASE2 |
| NCT00024245 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Memorial Sloan Kettering Cancer Center |
2001-05 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-11)
Check the
Pralatrexate
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.