What side effects are associated with this type of intervention?

The most common treatments for Non-Hodgkin's Lymphoma, particularly those involving hematopoietic cell transplantation (HCT), include autologous and allogeneic HCT. Autologous HCT can lead to side effects such as infections, anemia, and an increased risk of secondary malignancies like myelodysplastic syndrome. Allogeneic HCT, especially with nonmyeloablative or reduced intensity regimens, carries risks of graft-versus-host disease (GVHD), both acute and chronic, infections, and treatment-related mortality. Both types of HCT can also result in long-term complications such as organ toxicity and chronic immunosuppression.

What prior FDA approvals exist?

FDA-approved treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies such as rituximab, ofatumumab, and obinutuzumab, which target CD20 on B cells. Chemotherapy regimens like R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) are also commonly used. Hematopoietic cell transplantation (HCT), both autologous and allogeneic, has been approved for certain cases of NHL, particularly for relapsed or refractory disease. Additionally, CAR-T cell therapies such as axicabtagene ciloleucel and tisagenlecleucel have been approved for specific subtypes of NHL, offering new options for patients with advanced disease.

What other types of research exist?

Promising novel alternatives for Non-Hodgkin's Lymphoma patients include: 1) Chimeric Antigen Receptor T cell (CAR-T) therapy, which uses modified T cells to target and kill lymphoma cells; 2) Bispecific T-cell Engagers (BiTEs) like blinatumomab, which direct T cells to attack cancer cells; 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which deliver cytotoxic agents directly to cancer cells; and 4) Immune checkpoint inhibitors, which enhance the immune system's ability to fight cancer. These therapies offer targeted, less toxic alternatives to traditional stem cell transplantation.

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Stem Cell Transplantation

High-Dose Therapy and Autologous Stem Cell Transplant for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Craig Sauter, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Eligible for high-dose therapy and autologous stem-cell rescue

Complete or partial response by IWG Working Group or ICML Criteria to maximum of one salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy.

Must not have

Salvage therapy that includes involved field radiotherapy

HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 15

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how different amounts of a specific type of stem cell affect the outcomes of patients who receive their own stem cells back after treatment. It targets patients undergoing stem cell transplants. The treatment involves collecting, freezing, and re-infusing different amounts of these stem cells to see which dose works best. This method has been used in various clinical trials for treating multiple diseases, including multiple sclerosis and multiple myeloma.

Who is the study for?

Adults over 18 with relapsed or refractory DLBCL who've had one prior anthracycline-based chemotherapy can join. They should be fairly fit (KPS ≥ 70), have decent kidney function, and not too high bilirubin levels in the blood. Women and men must use birth control, and they shouldn't have HIV or other conditions that would interfere with stem cell procedures.

What is being tested?

The trial is examining how different doses of CD34+ stem cells affect recovery after a high-dose therapy followed by an autologous stem cell transplant in patients with certain types of B-cell lymphoma.

What are the potential side effects?

Potential side effects include reactions to medications like carmustine, etoposide, cytarabine, melphalan; complications from Plerixafor; issues related to leukapheresis; and risks associated with autologous stem cell transplantation such as infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for a treatment involving high-dose therapy and my own stem cells.

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I've had a good response to one round of chemotherapy without prior high-dose therapy or stem cell transplant.

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My total bilirubin is over 2.0 mg/dL, but my direct bilirubin is under 2.0 mg/dL.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My lymphoma returned or didn't respond after one treatment with anthracycline.

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I am mostly able to care for myself.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received targeted radiation therapy as part of my salvage treatment.

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I am HIV positive.

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I have had a stem cell transplant before.

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My treatment plan includes therapy after a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

progression-free survival (PFS)

Secondary study objectives

the impact of CD34+ cell dose on lymphocyte subset recovery

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 6-8 x10^6 CD34+ stem cells/kgExperimental Treatment4 Interventions

Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.

Group II: 3-4 x 10^6 CD34+ stem cells/kgActive Control4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Plerixafor

2011

Completed Phase 3

~710

Autologous Stem Cell Transplantation

2012

Completed Phase 3

~1000

leukapheresis

2004

Completed Phase 3

~230

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and hematopoietic cell transplantation (HCT). Chemotherapy targets rapidly dividing cancer cells, causing their death through DNA damage or inhibition of cell division. Immunotherapy, such as monoclonal antibodies like rituximab, targets specific antigens on lymphoma cells, marking them for destruction by the immune system. HCT, including autologous and allogeneic transplants, involves high-dose chemotherapy to eradicate cancer cells followed by stem cell infusion to regenerate healthy bone marrow. These treatments are vital for NHL patients as they offer potential long-term remission and a chance for cure, particularly in relapsed or refractory cases.