Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Anti-Inflammatory Agents

Antibodies

Antibodies, Monoclonal

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Immunoglobulins

Antibodies, Blocking

Immunotoxins

Daclizumab

40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.

40 micrograms/kg every other day (QOD) x 3 every 4 weeks

LMB-2

Robert J Kreitman, M.D.

This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating chronic lymphocytic leukemia (CLL) in patients who have a protein called cluster of differentiation 25 (CD25) on their cancer cells. LMB-2 is a recombinant immunotoxin. It is made up of two parts: a genetically engineered monoclonal antibody that binds to cancer cells with CD25 on their surface, and a toxin produced by bacteria that kills the cancer cells to which it binds. LMB-2 has killed CD 25-containing cells in laboratory experiments and has caused tumors in mice to shrink. Preliminary studies in humans have shown some effectiveness in shrinking tumors in patients with various types of lymph and blood cancers.

Patients 18 years of age and older with CLL who have CD25 receptor proteins on their cancer cells and whose disease has progressed within 2 years of treatment with fludarabine may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), echocardiogram, chest x-ray, computed tomography (CT) scans of the chest, abdomen and pelvis, and a bone marrow biopsy.

Participants receive up to six cycles of LMB-2 therapy. Each 28-day cycle consists of 30-minute infusions of LMB-2 on cycle days 1, 3, and 5. The drug is infused through an intravenous (IV) catheter (plastic tube placed in a vein) or a central venous line-an IV tube placed in a large vein in the neck or chest that leads to the heart. Patients are admitted to the National Institutes of Health (NIH) Clinical Center for the first treatment cycle. If the infusion is well tolerated, subsequent cycles may be given on an outpatient basis. In addition to drug therapy, patients undergo the following procedures:

* Blood draws: Blood is drawn before, during, and after each LMB-2 infusion to measure blood levels of the drug, evaluate its effects on the cancer cells, and monitor side effects. Blood tests are also done before and during each cycle to determine how the immune system is interacting with the drug.
* Disease evaluations: Patients undergo a physical examination, blood tests, chest x-ray, and EKG before each treatment cycle and at follow-up visits. With the patient's permission, CT scans, echocardiogram, and bone marrow biopsies may be repeated before some treatment cycles if these tests prove useful in evaluating the disease response to LMB-2.

Patients may receive up to six cycles of LMB-2 as long as their cancer does not worsen and they do not develop serious side effects. At the end of the treatment cycles, patients will have blood tests done weekly by their local physician, and the results will be sent to the NCI study investigators.

Background:

It is estimated that 30-50% of patients with CLL have tumors that express cluster of differentiation 25 (CD25) (Tac or IL2R). Normal resting T-cells are not sensitive to LMB-2 due to insufficient CD25 expression. LMB-2 is an anti-CD25 recombinant immunotoxin containing variable domains of MAb anti-Tac and truncated Pseudomonas exotoxin. A phase I trial at National Cancer Institute (NCI) found that the maximum tolerated dose (MTD) of LMB-2 was 40 microg/Kg IV given every other day for 3 doses (every other day (QOD) x3) with prophylactic IV fluid. The most common adverse events were transient fever, hypoalbuminemia and transaminase elevations. In that trial, one of eight patients with chronic lymphocytic leukemia had a partial remission. The other seven CLL patients had stable disease. In addition, four of four patients with hairy cell leukemia had responses (1 complete response (CR), 3 partial response (PRs)) and 3 other patients had PRs (1 cutaneous T-cell lymphoma (CTCL), 1 healthy donor (HD), 1 acute T-cell leukemia/lymphoma (ATL)). Because LMB-2 is cytotoxic to cells expressing CD25, CD25+ CLL patients are good candidates for further testing with LMB-2.

Objectives:

The purpose of this study is to determine the activity of anti-Tac(Fv)-PE38 (LMB- 2) in patients with Tac-expressing Chronic Lymphocytic Leukemia (CLL). The primary endpoint of this trial is response rate. We will also evaluate response duration, LMB-2 immunogenicity, pharmacokinetics, toxicity, and monitor soluble Tac levels in the serum.

Eligibility:

CD25 positive CLL or prolymphocytic leukemia (PLL) confirmed by flow cytometry of blood, with either lymphadenopathy, splenomegaly, hepatomegaly, hemoglobin less than 11 g/dl,

or platelets less than 100,000/ul.

Patients must have progression following purine analog or alkylating agent.

Labs required: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5- time upper limit,

albumin greater than or equal to 3, bilirubin less than equal to 2.2 (unless unconjugated greater than or equal to 80%)

and creatinine less than or equal to 1.4 (unless creatinine clearance greater than or equal to 50 ml/min).

Design:

Patients receive LMB-2 40 ug/Kg QOD x3 every 4 weeks in absence of neutralizing antibodies or progressive disease. 1st stage is 16 patients, to expand to 25 if greater than 1 of 16 patients respond.

Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia

A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Chronic Lymphocytic Leukemia

Response is measured by the 1996 National Cancer Institute (NCI) Working Group Criteria (NCIWG). Complete response is defined as no hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must resolve to \<1.0cm of 1-1.5cm at baseline, or \<1.5cm if \>1.5cm at baseline. Partial response is \>=50% decrease in peripheral blood lymphocytes count from the pretreatment baseline value. Progressive disease is \>=50% increase in the sum of the products of the greatest perpendicular dimensions of a t least 2 lymph nodes on two consecutive examinations 2 weeks apart (at least 1 node must be \>=2cm) or appearance of new palpable lymph nodes. Stable disease is characterized by not meeting the above criteria. For additional details about the NCIWG, see the protocol link module.

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

National Cancer Institute (NCI)

Dr. Robert Kreitman

LMB-2 in Chronic Lymphocytic Leukemia

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Robert J. Kreitman, M.D.

Complete Response

Partial Response

Progressive Disease

Stable Disease

Response Rate

Number of Participants With Adverse Events

Overall Study

Leukemia, T-Cell

Leukemia-Lymphoma, Adult T-Cell

Lymphoma

Adult T-cell Leukemia/lymphoma

Leukemia, T-cell, Chronic

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Administer cycle 1 with Fludarabine and Cyclophosphamide (FC) alone. Two weeks after starting cycle 1, begin up to 6 cycles of FC plus LMB-2 at minimum 20-day intervals.

Begin with 30 mcg/Kg intravenous (IV) on days 3, 5 and 7. Escalate to 40 mcg/Kg if dose limiting toxicity (DLT) in 0/3 or 1/6 at 30 mcg/Kg. Continue at 40 mcg/Kg if 0-1 of 6 have DLT at 40 mcg/Kg.

Days 1-3:

Patients 1-7, 10-14, and \>18:25mg/m\^2/day Patients 8 - 9:30 mg/m\^2/day Patients 15- 17:20 mg/m\^2/day

Days 1-3:

Patients 1-7, 10 -14, and \>18:250 mg/m\^2/day Patients 8 - 9:300 mg/m\^2/day Patients 15-17:200 mg/m\^2/day

BACKGROUND:

* Cluster of differentiation 25 (CD25) (p55, Tac or interleukin 2 receptor (IL2R) alpha) is strongly expressed in virtually 100% of patients with adult T-cell leukemia/lymphoma (ATL), a highly aggressive human T-lymphotropic virus type 1 (HTLV-1) related malignancy responding poorly to chemotherapy.
* In ATL, the humanized anti-CD25 monoclonal antibody (Mab) daclizumab produced 13-14% responses, and the anti-CD52 Mab Alemtuzumab (Campath-1H) produced response lasting greater than 2 months in 30% of 23 patients.
* LMB-2 is an anti-CD25 recombinant immunotoxin containing variable domains of murine MAb anti-Tac and truncated Pseudomonas exotoxin.
* In a phase I trial at National Cancer Institute (NCI), the maximum tolerated dose (MTD) of LMB-2 was 40 microg/Kg intravenous (IV) given every other day for 3 doses (every other day (QOD) times 3). LMB-2 induced greater than 90% tumor reduction rapidly in all 3 ATL patients on protocol, but achieved only 1 partial response due to rapid tumor progression and/or immunogenicity.
* In preclinical models, response from recombinant immunotoxins is limited by high concentrations of soluble receptor in the blood and especially in the interstitial space of the tumor. Synergism was observed with chemotherapy and immunotoxins, possibly due to reduction of soluble receptor in tumor interstitium.

OBJECTIVES:

-To determine, in nonrandomized fashion, if after verifying its safety, fludarabine and cyclophosphamide (FC) prior to LMB2 for ATL can result in low immunogenicity and a rate of major response lasting greater than 2 months, which may be an improvement over that demonstrated previously from Alemtuzumab (CAMPATH).

Secondary objectives:

* To determine the effect of 1 cycle of FC alone in ATL.
* To examine progression-free and overall survival in ATL after FC/LMB-2.
* Evaluate pharmacokinetics, toxicity, and monitor soluble CD25 and other tumor marker levels in the serum.
* To study the effects of LMB-2 plus FC on normal B- and T-cell subsets by fluorescence-activated cell sorting (FACS).

ELIGIBILITY:

* CD25 plus ATL, untreated or with prior therapy
* Eastern Cooperative Oncology Group (ECOG) 0-2, absolute neutrophil count (ANC), platelets and albumin at least 1000, 75,000, and 3.0.

DESIGN:

* Fludarabine 25 mg/m(2) IV days 1-3
* Cyclophosphamide 250 mg/m(2) IV days 1-3
* LMB-2 30-40 micro g/Kg IV days 3, 5 and 7.
* LMB-2 dose: Begin with 30 microg/Kg times 3. Escalate to 40 microg/Kg if dose limiting toxicity (DLT) in 0/3 or 1/6 at 30 microg/Kg. Continue at 40 microg/Kg if 0-1 of 6 have DLT at 40 microg/Kg.
* Administer cycle 1 with FC alone. Two weeks after starting cycle 1, begin up to 6 cycles of FC plus LMB-2 at minimum 20-day intervals.
* Accrual goals: 29-37 patients, which includes 4 replacements....

BACKGROUND:

* Cluster of differentiation 25 (CD25) (p55, Tac or interleukin receptor 2 (IL2Ra) is strongly expressed in virtually 100 % of patients with adult T-cell leukemia/lymphoma (ATL), a highly aggressive human T-lymphotropic virus type 1 (HTLV-1) related malignancy responding poorly to chemotherapy.
* In adult T-cell leukemia (ATL), the humanized anti-CD25 monoclonal antibody (Mab) daclizumab produced 13-14 % responses, and the anti-CD52 Mab Alemtuzumab (Campath- 1H) produced response lasting \> 8 weeks in of 30 % of 23 patients.
* LMB-2 is an anti-CD25 recombinant immunotoxin containing variable domains of murine MAb anti-Tac and truncated Pseudomonas exotoxin.
* In a phase I trial at National Cancer Institute (NCI), the maximum tolerated dose (MTD) of LMB-2 was 40 mcg/Kg dose intravenous (IV) given every other day for 3 doses (every other day (QOD) x3). LMB-2 induced \> 90 % tumor reduction rapidly in all 3 ATL patients on protocol, but achieved only 1 partial response due to rapid tumor progression and/or immunogenicity.
* In preclinical models, response from recombinant immunotoxins is limited by high concentrations of soluble receptor in the blood and especially in the interstitial space of the tumor. Synergism was observed with chemotherapy and immunotoxins, possibly due reduction of soluble receptor in tumor interstitium.

OBJECTIVES:

* To determine, in nonrandomized fashion, if after verifying its safety, fludarabine and cyclophosphamide (FC) prior to LMB2 for ATL can result in low immunogenicity and a rate of major response lasting \> 8 weeks which may be an improvement over that demonstrated previously from Alemtuzumab (CAMPATH).
* Secondary objectives

  * To determine the effect of 1 cycle of FC alone in ATL.
  * To examine progression-free and overall survival in ATL after FC/LMB-2.
  * Evaluate pharmacokinetics, toxicity, and monitor soluble CD25 and other tumor marker levels in the serum.
  * To study the effects of LMB-2 +FC on normal B- and T-cell subsets by FACS.

ELIGIBILITY:

* CD25+ ATL, untreated or with prior therapy, leukemic type without malignant masses \> 4 cm.
* Eastern Cooperative Oncology Group (ECOG) 0-2, absolute neutrophil count (ANC), platelets and albumin at least 1000, 75,000, and 3.0 respectively.

DESIGN:

* IV fludarabine and cyclophosphamide (FC) days 1-3 (doses listed respectively)
* Patients 1-7 and 10-14, and \>18: 25 and 250 mg/m\^2/day
* Patients 8-9: 30 and 300 mg/m\^2/day
* Patients 15-17: 20 and 200 mg/m\^2/day
* LMB-2 dose: Begin with 30 mcg/Kg IV on days 3,5 and 7. Escalate to 40 mcg/Kg if dose limiting toxicity (DLT) in 0/3 or 1/6 at 30 mcg/Kg. Continue at 40 mcg/Kg if 0-1 of 6 have DLT at 40 mcg/Kg.
* Administer cycle 1 with FC alone. Two weeks after starting cycle 1, begin up to 6 cycles of FC plus LMB-2 at minimum 20 day intervals.
* Accrual goals: 29-37 patients, which includes 4 replacements.

Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia

All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.

Response is based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma and must last \>8 weeks to meet the primary endpoint of the study. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion. Stable disease is neither a response nor progressive disease. Progressive disease is appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.

The maximum analyte concentration in serum was reported using a cytotoxicity assay measuring the level of LMB-2 in the plasma and using purified LMB-2 as a standard curve.

PFS was determined by the Kaplan Meier method beginning at the on study date and continuing until progression or last follow-up without progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.

OS is the time between the first day of treatment to the day of disease progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

DLT is a grade II-IV LMB-2 or fludarabine and cyclophosphamide (FC)-related toxicity, except vascular leak syndrome, alopecia, grade II-III allergic reaction with asymptomatic bronchospasm or urticarial is considered DLT. Grade III aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and fever are not considered DLT. Grade IV creatine phosphokinase associated with any other DLT or not resolving to \<grade II within 2 weeks is considered DLT. Hematologic toxicity is not considered DLT unless it fails to resolve to \<grade 2 or baseline by day 18 after cycle 1 or after day 25 after cycles 2-7. DLT from hepatotoxicity, creatine phosphokinase, and vascular leak syndrome is assumed from LMB-2, and hematologic toxicity from fludarabine and cyclophosphamide. Grade III proteinuria lasting \<2 weeks after the last dose of LMB-2 is not considered DLT, and needs to resolve to grade 0-2 prior to retreatment.

Tumor tissue, including lymph node or skin biopsies was examined and analysis performed by flow cytometry to determine the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.

AUC is a measure of the plasma concentration of drug over time. It is used to characterize drug absorption. Plasma levels were analyzed by cytotoxicity assay.

Peripheral blood was obtained and analyzed by flow cytometry.

Blood was drawn prior to each cycle of LMB-2 to determine if the level, \>75% neutralization of 1000ng/ml of LMB-2 of neutralizing antibodies is too high to give additional LMB-2. Analysis was performed by cytotoxicity assay.

Duration of response is defined as a response lasting for at least 4 weeks but \>8 weeks and is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion.

Dilutions of patient plasma was tested by cytotoxicity assays to determine plasma clearance of LMB-2.The CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Dilutions of patient plasma were tested by cytotoxicity assays to determine volume of distribution of LMB-2. Volume distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. This was measured during the first 24 hours after administration of the dose on cycle 2 day 1.

Dilutions of patient plasma was tested by cytotoxicity assays to determine half life. Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.

Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 (mild), Grade 4 (life threatening) and Grade 5 (death).

Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Principal Investigator

Leukemic patients receiving LMB-2 and at least 25+250 mg/m\^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.

Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC

Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m\^2 of fludarabine cyclophosphamide (FC).

All Other Patients

Total

African American

Tabago, Black

Peruvian, Hispanic

American from Jamaica, Black

Jamaican, Black

Ethiopian, Black

Jamaican

Barbados, Black

American, from Ghana, Black

Race/Ethnicity, Customized

CHOP

EPOCH-C

C, ESHAP, PTX, Gem

Medi507, Ontak, HAT

CHOP, C

EPOCH-RS

None

Hydroxyurea

CHOP, Hydroxyurea

LSG-15, radiation

Prior treatments included cyclophosphamide, adriamycin, vincristine, and prednisone (CHOP), these 4 agents with etoposide (EPOCH) and campath (C or alemtuzumab, together EPOCH-C), etoposide, methylprednisolone, cytarabine, and cisplatin (ESHAP), pralatrexate (PTX), gemcitabine (Gem), siplizumab (Medi507), denileukin diftitox (Ontak), daclizumab or humanized anti-Tac (HAT) and EPOCH with rituximab and siplizumab (EPOCH-RS). The LSG-15 regimen includes prednisone, adriamycin, carmustine, etoposide, carboplatin, and vinorelbine.

One participant was not evaluable. Participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.

Prior Treatment

Acute

Type of Leukemia

Bone, lung, skin

Thigh (skin)

Pelvis

Muscle

Skin

Lymph node (LN)

Spleen, LN

Subcutaneous

Bone, subcutaneous

Spleen

Extravascular sites

Participants with High Lactate Hydrogenase (LDH)

High Calcium++ is a corrected calcium \> 2.74

Participants with High Calcium++

0 cells

1 cell

80 cells

206 cells

246 cells

408 cells

450 cells

687 cells

5,604 cells

7,737 cells

8,216 cells

13,153 cells

24,112 cells

210,000 cells

213,000 cells

Adult T-cell Leukemia (ATL) cells/mm^3 in the Peripheral Blood

<1 cm tumor

1.9 cm tumor

2 cm tumor

2.2 cm tumor

5.6 cm tumor

5.8 cm tumor

6 cm tumor

9 cm tumor

15, 2.5 cm tumor

17 cm tumor

17.5 cm tumor

18.5, 1.7 cm tumor

20, 1.8 cm tumor

Maximum tumor size is listed, respectively, with the maximum spleen diameter.

Maximum tumor size

Overall Response

Not Evaluable

All 10 patients receiving LMB-2 and at least 25+250 mg/m\^2 Fludarabine/Cyclophosphamide (FC) were evaluable for response.

Of the 8 other patients, only 5 received LMB-2 and were therefore evaluable for response.

Percentage of Participants With a Minimally Durable Clinical Response Rate

Peak Level of LMB-2 in Adult T-Cell Lymphoma

Published response duration of 15 patients with leukemic adult T cell leukemia treated with Alemtuzumab.

Progression Free Survival (PFS)

One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.

Overall Survival (OS)

Number of Participants With Serious and Non-serious Adverse Events

Number of Participants With Dose Limiting Toxicity (DLT)

Soluble CD25, lowest post-treatment (nadir) value

Median sCD25 Nadir for responders

Median sCD25 Nadir for non-responders

Median sCD25 PRE-treatment for responders

Median sCD25 PRE-treatment for non-responders

The number 8 represents the number of responders in the Arm/Group and the number 2 represents the number of non-responders in the Arm/Group.

Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders

Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2

Area Under the Plasma Concentration (AUC) - LMB2

Normal T-cells

Normal CD4+ cells

Normal CD8+ cells

Normal B-cells

One patient did not have flow cytometry measuring it.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia	NCT00077922	Leukemia Lymphocytic Chronic	LMB-2	18 Years -	National Institutes of Health Clinical Center (CC)
Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia	NCT00924170	Adult T-Cell Le...	LMB-2 Fludarabine Cyclophosphamid...	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People	NCT04844489	Autoimmune or A... HIV Multiple Sclero... Solid Tumors or... Solid Organ Tra...	Blood samples f...	18 Years -	Assistance Publique - Hôpitaux de Paris
Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People	NCT04844489	Autoimmune or A... HIV Multiple Sclero... Solid Tumors or... Solid Organ Tra...	Blood samples f...	18 Years -	Assistance Publique - Hôpitaux de Paris
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia	NCT00077922	Leukemia Lymphocytic Chronic	LMB-2	18 Years -	National Institutes of Health Clinical Center (CC)
Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the HUS	NCT05618275	BK Virus Infect...		1 Year - 19 Years	University Hospital, Strasbourg, France
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia	NCT00077922	Leukemia Lymphocytic Chronic	LMB-2	18 Years -	National Institutes of Health Clinical Center (CC)
Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples	NCT04391647	Human Papilloma...	First-void urin... Blood draw	18 Years - 25 Years	Universiteit Antwerpen
Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the HUS	NCT05618275	BK Virus Infect...		1 Year - 19 Years	University Hospital, Strasbourg, France

Spots Global Cancer Trial Database for neutralizing antibodies