CD47 Antagonist ALX148 for Composite Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Composite Lymphoma+27 More
CD47 Antagonist ALX148 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of ALX148, rituximab and lenalidomide may be effective in treating patients with indolent and aggressive B-cell non-Hodgkin lymphoma.

See full description

Eligible Conditions

  • Composite Lymphoma
  • Aggressive B-Cell Non-Hodgkin Lymphoma
  • Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Ann Arbor Stage IV Grade 3 Follicular Lymphoma
  • Refractory High Grade B-Cell Lymphoma
  • Refractory Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
  • Ann Arbor Stage III Grade 3 Follicular Lymphoma
  • indolent B-cell non-Hodgkin Lymphoma (NHL)
  • Ann Arbor Stage IV Marginal Zone Lymphoma
  • Refractory Follicular Lymphoma
  • Ann Arbor Stage IV Grade 1 Follicular Lymphoma
  • Ann Arbor Stage III Grade 2 Follicular Lymphoma
  • Refractory Grade 3b Follicular Lymphoma
  • Ann Arbor Stage III Marginal Zone Lymphoma
  • Refractory Marginal Zone Lymphoma
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
  • Richter's Syndrome
  • Ann Arbor Stage IV Grade 2 Follicular Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Composite Lymphoma

Study Objectives

This trial is evaluating whether CD47 Antagonist ALX148 will improve 2 primary outcomes and 6 secondary outcomes in patients with Composite Lymphoma. Measurement will happen over the course of Up to 28 days.

Day 28
Overall response rate (ORR) (CR + partial response [PR])
At 6 months
Complete remission (CR) rate (Phase II)
Day 28
Overall survival (OS)
Progression-free survival (PFS)
Year 3
Duration of response
Up to 28 days
Recommended phase II dose (RP2D) and schedule of ALX148 (Phase I)
Up to 30 days
Incidence of treatment-emergent AEs requiring temporary or permanent discontinuation of study drug or dose reductions
Incidence of treatment-emergent adverse events (AEs)

Trial Safety

Safety Progress

1 of 3

Other trials for Composite Lymphoma

Trial Design

1 Treatment Group

Treatment (ALX148, rituximab, lenalidomide)
1 of 1
Experimental Treatment

This trial requires 52 total participants across 1 different treatment group

This trial involves a single treatment. CD47 Antagonist ALX148 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment (ALX148, rituximab, lenalidomide)Patients receive ALX148 IV over 1 hour once on days 1, 8, 15 and 22, or days 1 and 15, or day 1 depending on dose level. Patients also receive rituximab IV over 4-6 hours on days 1, 8, 15 and 22 of cycle 1, then on day 1 of cycles 2-6, and lenalidomide PO QD on days 1-21 of cycles 1-6. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the time by which measurement criteria for cr or pr, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the time by which measurement criteria for cr or pr, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Composite Lymphoma or one of the other 27 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The first phase includes patients who have been diagnosed with B-cell NHL, including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, large B-cell lymphoma (including transformed marginal zone lymphoma [MZL], transformed follicular lymphoma [FL], Richter syndrome with absolute lymphocyte count [ALC] < 5,000 10^9/L, FL grade 3B, high grade B-cell lymphoma and primary mediastinal B-cell lymphoma), and composite lymphoma (concomitant indolent and aggressive B-NHL). show original
The text states that patients who have failed at least one line of systemic therapy and are not eligible for a known standard of care curative treatment option will be enrolled in Phase I show original
The definition of bulky disease is a nodal or extranodal (except spleen) mass greater than 7 cm in diameter, or involvement of at least 3 nodal or extranodal sites (each with a diameter greater than 3 cm). show original
The individual has at least one of the following symptoms: a fever that is higher than 38 degrees Celsius, night sweats, and weight loss that is greater than 10 percent within the prior six months. show original
They have not received any other type of treatment for their lymphoma before this phase. show original
: 1) extensive disease with involvement of multiple organs, 2) positive immunohistochemistry for B-cell receptor (BCR) or CD20, 3) extranodal disease, or 4) presence of tumor cell blasts in the peripheral blood Patients who have a high tumor burden are defined by meeting one or more of the following Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria: 1) extensive disease with involvement of multiple organs, 2) positive immunohistochemistry for B-cell receptor (BCR) or CD20, 3) extranodal disease, or 4) presence of tumor cell blasts in the peripheral blood. show original
If the organ is compressed or involved, the prognosis depends on the severity of the compression or involvement. show original
lasting more than 1 week warrants treatment with rituximab A low level of hemoglobin, platelets, or neutrophils for more than a week may mean that you have lymphoma and should be treated with rituximab. show original
The person has a lymphoma that has been confirmed by a microscope, and it is one of three types: follicular lymphoma, grade 1, 2, or 3a; or marginal zone lymphoma. show original
Symptomatic splenomegaly

Patient Q&A Section

Have there been any new discoveries for treating lymphoma, diffuse?

"There have been many advances in treating lymphoma patients, but the outcomes remain unsatisfactory. It seems that we cannot expect dramatic breakthroughs for treating lymphoma until we understand the biology of this disease better. Future studies need to focus on identifying specific molecular markers to predict response to treatment and to identify new target molecules for developing novel agents." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in cd47 antagonist alx148 for therapeutic use?

"The CD47 antigen has been shown to be overexpressed in B cell lymphomas including mantle-cell lymphoma and Burkitt's lymphoma. Therefore, targeting solely CD47 using monoclonal antibody therapy does not appear to be sufficient for effective treatment. In addition, there is increasing evidence that the CD47 molecule plays a role in modulating BCR signalling and may therefore not be an ideal target in treating these cancers." - Anonymous Online Contributor

Unverified Answer

What is cd47 antagonist alx148?

"Results from a recent paper shows that CD47 blockade may be safely combined with chemotherapy in patients with low-grade non-Hodgkin's lymphoma and in mantle cell lymphoma without increasing the rate of myelosuppression. The combination of CD47 antagonism with standard chemotherapy allows for a targeted approach to chemotherapy." - Anonymous Online Contributor

Unverified Answer

Has cd47 antagonist alx148 proven to be more effective than a placebo?

"We were not able to demonstrate any significant difference in PFS between patients treated with Alx148 or a placebo. In this exploratory analysis of PFS using an intent to treat analysis, there was no indication of a benefit of Alx148 over a placebo. However, future studies will have to confirm our findings." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, diffuse?

"Tumor-related factors such as stage, type of cell, and presence of B-cell markers influence response. Drugs used for other cancers (e.g., anthracyclines, alkylating agents, taxanes) are often used as well as chemotherapy regimens for lymphomas. Complete responders to immunotherapy agents or radiotherapy were also treated with chemotherapy or radiotherapy plus autoimmunotherapy. The majority of patients who responded to therapy went into remission. Most of these patients continued with treatment and showed disease stabilization in about half of them. Treatment with conventional or high-dose chemotherapy and autologous stem-cell transplantation has been successful in improving progression-free survival." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma, diffuse?

"The overall 5 year survival rate for diffuse large B-cell lymphoma is 60%. Patients who have an age >60 years or are white have significantly better survival rates than patients who do not meet these criteria. Patients who are black, Hispanic, under age 40 years old or with a poorer performance status has a worse overall survival rate." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing lymphoma, diffuse?

"The risk of developing diffuse non-Hodgkin's lymphoma increases significantly with age. After 55 years of age, the risk exceeds that for all other subtypes combined. The most common form of diffuse lymphoma is usual variant Hodgkin's disease." - Anonymous Online Contributor

Unverified Answer

Can lymphoma, diffuse be cured?

"LYM-D, although difficult to diagnose, has a long survival time if treated properly utilizing modern chemotherapy regimens. After this disease has been diagnosed, even if its symptoms do not resolve, there is still a chance that the cancer can be cured." - Anonymous Online Contributor

Unverified Answer

Is cd47 antagonist alx148 typically used in combination with any other treatments?

"The addition of alx148 to standard chemotherapy does not appear to improve survival in patients with mantle cell lymphoma. The use of alx148 should be considered when other treatments are being considered." - Anonymous Online Contributor

Unverified Answer

What causes lymphoma, diffuse?

"There are several risk factors for DLBCL, including: • HIV infection;\n• Immunosuppressive therapy (e.g. peripheral TSLP);\n• Smoking;\n• Exposure to pesticides;\n• Occupational exposures (e.g. exposure to benzene, toluene, styrene, etc." - Anonymous Online Contributor

Unverified Answer

How quickly does lymphoma, diffuse spread?

"The differences in survival between patients with and without radiotherapy suggest that the duration of disease has important prognostic significance, and that early treatment improves long-term survival. We therefore recommend that patients with node-positive stage I and II B-cell lymphoma should be treated within 4 weeks after diagnosis. Patients with stages III and IV disease should be treated before chemotherapy has been given." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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