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Treatment (Allogeneic PBSCT) for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Dolores Grosso, DNP, CRNP

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

Study Summary

This trial is comparing the survival rates of patients with a less severe form of their disease who receive a HSCT from a related donor, to the survival rates of similar patients in the medical literature who receive a less intense HSCT.

Eligible Conditions

Follicular Lymphoma
Acute Promyelocytic Leukemia
Myelodysplastic/Myeloproliferative Neoplasm
Hodgkin's Lymphoma
Lymphomatoid Granulomatosis
Adult Acute Myeloid Leukemia
Aplastic Anemia
Essential Thrombocythemia
Myelodysplastic Syndrome
Splenic Marginal Zone Lymphoma
Lymphoma
Adult Hodgkin's Lymphoma
Childhood Acute Myeloid Leukemia
Nodal Marginal Zone Lymphoma
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Neutrophilic Leukemia
Chronic Myelomonocytic Leukemia
Nasal Lymphoma
Polycythemia Vera
Mastocytosis
Anemia With Ringed Sideroblasts
Myelomonocytic Leukemia
Large Granular Lymphocyte Leukemia
Cutaneous T-Cell Lymphoma
Hairy Cell Leukemia
Primary Myelofibrosis
Multiple Myeloma
Diffuse Large B-Cell Lymphoma
Waldenström's Macroglobulinemia
Myelodysplastic Syndromes (MDS)
Marginal Zone Lymphoma
Leukemia
MALT Lymphoma
Anemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS) in patients with haploidentical family donors with hematological malignancies in morphological or radiographic remission or with chemosensitive, indolent diseases

Secondary outcome measures

Engraftment Rates

Incidence and severity of GVHD, graded according to standard criteria

Incidence of Treatment Related Mortality (TRM)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Allogeneic PBSCT)Experimental Treatment9 Interventions

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mycophenolate mofetil

FDA approved

Cyclophosphamide

FDA approved

Tacrolimus

FDA approved

Donor Lymphocyte Infusion (DLI)

2014

Completed Phase 3

~190

Peripheral blood stem cell transplantation (PBSCT)

2011

Completed Phase 2

~40

Fludarabine

FDA approved

Allogeneic hematopoietic stem cell transplantation

2016

Completed Phase 2

~290

Busulfan

FDA approved

Total Body Irradiation (TBI)

2016

Completed Phase 3

~1220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,871 Total Patients Enrolled

Dolores Grosso, DNP, CRNPPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

8 Previous Clinical Trials

145 Total Patients Enrolled

Neal Flomenberg, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

14 Previous Clinical Trials

316 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared allogeneic peripheral blood stem cell transplantation for use?

"Since this is a Phase 2 trial, there is some evidence supporting the safety of Allogeneic PBSCT but not its efficacy. Our team has rated it as a 2."

Answered by AI

Could you give me a ballpark number of people who have signed up for this research project?

"This study is no longer active, as the last update was on September 14th, 2022. For other options, 6328 trials are currently enrolling patients with chronic lymphocytic leukemia and 1067 studies for Treatment (Allogeneic PBSCT) are actively searching for patients."

Answered by AI

Are there any available spots left for participants in this experiment?

"The clinical trial in question, which was first posted on 8/4/2011 and updated on 9/14/2022, is not currently enrolling patients. There are, however, 7395 other trials that are presently looking for participants."

Answered by AI

Are there other ongoing or completed studies that have used allogeneic PBSCT?

"As of now, 1067 trials are being conducted studying Treatment (Allogeneic PBSCT). 187 of those active studies are in Phase 3. The majority of trials for Treatment (Allogeneic PBSCT) are based in Philadelphia, Pennsylvania; however, 29777 locations around the world are running trials for this treatment."

Answered by AI

What maladies are commonly treated with Allogeneic PBSCT?

"Treatment (Allogeneic PBSCT) can be used to fight and manage symptoms for patients with lung cancer, dermatitis, atopic conditions, and multiple sclerosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies

2011. "A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01384513.