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Pralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle.

Pralatrexate Injection

Owen O'Connor, MD, PhD

Primary

• Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)

Secondary

* Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL
* Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation

This is a Phase 2, single arm, non-randomized, open-label, multi-center study designed to evaluate the safety and effectiveness of pralatrexate when administered with vitamin B12 and folic acid supplementation to patients with relapsed or refractory PTCL.

Pralatrexate will be given over 3-5 minutes intravenously (IV), which means through a vein. If pralatrexate is tolerated well, the patient will receive IV injections of pralatrexate every week for 6 weeks, followed by 1 week without receiving pralatrexate. These 7 week cycles will be repeated depending on response and tolerability.

Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

A Multi-Center, Phase 2, Open-Label Study of (RS)-10-Propargyl-10-Deazaaminopterin (Pralatrexate) With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.

Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence \& reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.

Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status \& survival. Pts who did not have response assessments after baseline were censored at treatment day 1.

Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.

Acrotech Biopharma Inc.

Serious AEs and AEs regardless of causality and all grades presented below. Symptoms present at baseline, AEs, and intercurrent illnesses were monitored at every study visit. Patients were instructed to report AEs to the investigator. All AEs including observed or volunteered problems, complaints, or symptoms were recorded.

All patients who received at least one dose of pralatrexate

Full Population

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Canada

Europe

Region of Enrollment

Outcome Measure (primary and secondary), Serious Adverse Event and Adverse Event data presented have a cut-off date of August 2009.

Michael Saunders, M.D.

All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.

Evaluable Population

Analysis was per protocol and was based on number of patients (pts) who responded in the evaluable population. The evaluable population consisted of all pts who received at least one dose of pralatrexate and had an eligible peripheral T-cell lymphoma (PTCL) histopathological subtype confirmed by central pathology review.

Response Rate Per Independent Central Review

Analysis was per protocol. Based on the number of responding pts (n=32) in the evaluable population (n=109), as assessed by independent central review protocol.

Duration of Response Per Independent Central Review

Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored. Pts were censored for lack of PD, receipt of other anti-cancer therapy before PD, termination of study/follow-up for response, and transplant.

Progression-free Survival Per Independent Central Review

Analysis was per protocol, based on the number of patients (pts) who had an event (death or censoring) at the time of data cut-off.

Overall Survival Per Independent Central Review

All patients who received at least one dose of pralatrexate. Patients continued pralatrexate until protocol defined criteria for discontinuation or 24 months of treatment.

Treatment With Pralatrexate

Survival Follow-up, After Pralatrexate

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Genetic analysis will be performed in patients who got a successful PDX

Serology and genetic analyses will be performed in patients blood samples

blood samples collection

Judith PASSILDAS, PhD

Judith PASSILDAS JAHANMOHAN, PhD

Xavier DURANDO, Professor

Patient derived xenografts (PDX) from mammary tumors are usually made from metastatic tumors. Indeed, PDX from primitive mammary tumors or after neoadjuvant treatment are still rare. However, the realization of such PDX (from primitive mammary tumors or after neoadjuvant treatment) would make it possible to have a better knowledge of the tumor heterogeneity to the therapeutic response, to explore the models of tumor evolution during metastatic progression and also observe the mechanisms of tumor resistance in the case of non-metastatic tumors. It therefore seems necessary to develop PDX from primitive tumors in order to observe firstly the success rate of PDX; on the other hand, the drift of the initial heterogeneity, measured by comparison of the histomolecular profile of the tumors with that of the PDXs. It aims to develop xenografts from tumor samples from surgical specimens of patients with triple negative or luminal B breast cancer.

The intervention consists in the realization of additional blood samples to carry out serologies and genetic analyses

Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer

A Prospective Study of Xenografts Development From Samples Taken From Surgical Specimens of Patients With Triple Negative or Luminal B Breast Cancer

PDX will be realized from patient tumor by transplanting a small fragment in a nude mouse. Once the tumor is enough grown up, the tumor is extracted to repeat this step 3 times until we get the fourth PDX with a successful tumor growth.

Comparaison of initial tumor histological subtype with PDX histological subtype

Comparaison of initial tumor expression of estrogen receptors with PDX expression of estrogen receptors

Comparaison of initial tumor expression of progesterone receptors with PDX expression of progesterone receptors

Comparaison of initial tumor's ERBB2 gene amplification status with PDX's ERBB2 gene amplification status

Comparaison of initial tumor expression of androgen receptors with PDX expression of androgen receptors

Comparaison of initial tumor molecular expression with PDX molecular classification (luminal A, luminal B, HER2 enriched or triple negative)

Comparaison of genetic alterations between intial tumor, PDX and blood sample

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma	NCT00364923	Peripheral T-ce...	Pralatrexate In...	18 Years -	Acrotech Biopharma Inc.
Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma	NCT00364923	Peripheral T-ce...	Pralatrexate In...	18 Years -	Acrotech Biopharma Inc.
Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer	NCT04133077	Breast Cancer F...	blood samples c...	18 Years -	Centre Jean Perrin
Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma	NCT00364923	Peripheral T-ce...	Pralatrexate In...	18 Years -	Acrotech Biopharma Inc.

Spots Global Cancer Trial Database for pdx

Every month we try and update this database with for pdx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pdx

Every month we try and update this database with for pdx cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pdx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.